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155 NCRP REPORT No. 155

MANAGEMENT OF RADIONUCLIDE THERAPY PATIENTS


MANAGEMENT OF
RADIONUCLIDE
THERAPY PATIENTS
NCRP REPORT No. 155

Management of
Radionuclide Therapy
Patients

Recommendations of the
NATIONAL COUNCIL ON RADIATION
PROTECTION AND MEASUREMENTS

December 11, 2006

National Council on Radiation Protection and Measurements


7910 Woodmont Avenue, Suite 400 / Bethesda, MD 20814-3095

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LEGAL NOTICE
This Report was prepared by the National Council on Radiation Protection and
Measurements (NCRP). The Council strives to provide accurate, complete and use-
ful information in its documents. However, neither NCRP, the members of NCRP,
other persons contributing to or assisting in the preparation of this Report, nor any
person acting on the behalf of any of these parties: (a) makes any warranty or rep-
resentation, express or implied, with respect to the accuracy, completeness or use-
fulness of the information contained in this Report, or that the use of any
information, method or process disclosed in this Report may not infringe on pri-
vately owned rights; or (b) assumes any liability with respect to the use of, or for
damages resulting from the use of any information, method or process disclosed in
this Report, under the Civil Rights Act of 1964, Section 701 et seq. as amended 42
U.S.C. Section 2000e et seq. (Title VII) or any other statutory or common law theory
governing liability.

Disclaimer
Any mention of commercial products within NCRP publications is for informa-
tion only; it does not imply recommendation or endorsement by NCRP.

Library of Congress Cataloging-in-Publication Data

Management of radionuclide therapy patients.


p. cm. — (NCRP report ; no. 155)
“December 11, 2006.”
“Prepared by NCRP Scientific Committee 91-1 on Precautions in the Manage-
ment of Patients Who Have Received Therapeutic Amounts of Radioactivity”--Pref.
Supersedes NCRP Report No. 37, Precautions in the Management of Patients
Who Have Received Therapeutic Amounts of Radionuclides, 1970.
Includes bibliographical references and index.
ISBN-13: 978-0-929600-92-5
ISBN-10: 0-929600-92-4
1. Radiotherapy--Standards--United States. 2. Radiotherapy--United States--
Safety measures. 3. Radiation--Safety regulations--United States I. National Coun-
cil on Radiation Protection and Measurements. II. National Council on Radiation
Protection and Measurements. Scientific Committee 91-1 on Precautions in the
Management of Patients Who Have Received Therapeutic Amounts of Radioactivity.
III. Series.
[DNLM: 1. Radiotherapy--standards--Guideline. 2. Radiation Injuries--preven-
tion & control--Guideline. 3. Radiation Protection--methods--Guideline.
WN 250 M266 2007]
RM854.M36 2007
615.8'42--dc22
2007010967

Copyright © National Council on Radiation


Protection and Measurements 2007
All rights reserved. This publication is protected by copyright. No part of this publica-
tion may be reproduced in any form or by any means, including photocopying, or
utilized by any information storage and retrieval system without written permission
from the copyright owner, except for brief quotation in critical articles or reviews.

[For detailed information on the availability of NCRP publications see page 234.]

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Preface

This Report was developed under the auspices of Program Area


Committee 4 of the National Council on Radiation Protection and
Measurements (NCRP) concerned with radiation protection in
medicine. The Report supersedes NCRP Report No. 37, Precautions
in the Management of Patients Who Have Received Therapeutic
Amounts of Radionuclides, which was issued in 1970. Thus, this
Report addresses the current issues and practices that have devel-
oped during the long period before this updating. The Report
provides radiation protection guidance for physicians, medical
physicists, health physicists, nuclear pharmacists, health care pro-
fessionals, and visitors to medical facilities, family members of the
patients as well as members of the public who may be involved in
the treatment and care of radionuclide therapy patients. This
Report also confirms the recommendations of NCRP Commentary
No. 11 on Dose Limits for Individuals Who Receive Exposure from
Radionuclide Therapy Patients, and confirms or updates related
recommendations in other earlier NCRP publications identified in
Section 1 of this Report.
Throughout the Report amounts of activity are stated for the
practices or procedures under discussion. This is done only
for illustration purposes and these amounts are not to be taken as
actual prescriptions for the particular practices or procedures. The
prescription of activity for a patient is the sole responsibility of
the prescribing physician.
This Report is dedicated to Dr. John S. Laughlin of the Memorial
Sloan-Kettering Cancer Center, a pioneer in the field of medical
physics, who contributed to many advancements in the treatment
of cancer, and who was a member of the Scientific Committee that
produced the first report issued in 1970 and who died in late 2004.
This Report was prepared by NCRP Scientific Committee 91-1
on Precautions in the Management of Patients Who Have Received
Therapeutic Amounts of Radioactivity. Serving on Scientific Com-
mittee 91-1 were:

Jean St. Germain, Chairman


Memorial Sloan-Kettering Cancer Center
New York, New York

iii

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iv / PREFACE

Members
Edward B. Silberstein Richard J. Vetter
University of Cincinnati Mayo Clinic
Medical Center Rochester, Minnesota
Cincinnati, Ohio
Jeffrey F. Williamson Pat D. Zanzonico
Washington University Memorial Sloan-Kettering
Medical Center Cancer Center
St. Louis, Missouri New York, New York

Liaisons
Jerrold T. Bushberg Sarah S. Donaldson
University of California, Stanford University School
Davis School of Medicine of Medicine
Sacramento, California Stanford, California

NCRP Secretariat
Constantine J. Maletskos, Staff Consultant, 2003–2006
William M. Beckner, Senior Staff Scientist, 2001–2003
James A. Spahn, Jr., Senior Staff Scientist, 1994–2000
Cindy L. O’Brien, Managing Editor
David A. Schauer, Executive Director

The Council wishes to express its appreciation to the Committee


members, liaisons and consultants for the time and effort devoted
to the preparation of this Report.
Financial support was provided by the U.S. Nuclear Regulatory
Commission (NRC) and the National Cancer Institute (NCI Con-
tract #2 R24 CA 074296-09A1). The contents of this Report are the
sole responsibility of NCRP, and do not necessarily represent the
official views of NRC or the NCI, National Institutes of Health.

Thomas S. Tenforde
President

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Contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Dose Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Patient Confinement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.1 Brief History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.2 Research with Radioactive Material . . . . . . . . . . . . . . . . . . .7
1.3 Principles of Radiopharmaceutical Therapy. . . . . . . . . . . . .9
1.4 Principles of Brachytherapy . . . . . . . . . . . . . . . . . . . . . . . .10
1.5 General Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

2. Radiation Safety Program in a Medical Facility. . . . . . . . .14


2.1 Description of the Radiation Safety Program. . . . . . . . . . .14
2.2 Current Dose Limits and Radiation Protection Goals . . . .15
2.2.1 Recommended Dose Limits . . . . . . . . . . . . . . . . . .15
2.2.2 Specific Definitions . . . . . . . . . . . . . . . . . . . . . . . . .17
2.2.3 Dose Limits for Patients’ Families and the
Public. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
2.2.4 Personal Monitoring and Bioassays . . . . . . . . . . .20
2.3 Staffing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
2.3.1 Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
2.3.2 Radiation Safety Officer . . . . . . . . . . . . . . . . . . . . .22
2.3.3 Medical Physicist and Nuclear Pharmacist . . . . .23
2.3.4 Radiation Therapist and Nuclear-Medicine
Technologist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
2.3.5 Dosimetrist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
2.3.6 Nurse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
2.3.7 Physicians-in-Training . . . . . . . . . . . . . . . . . . . . . .25
2.4 Radiation Safety Committee . . . . . . . . . . . . . . . . . . . . . . . .26
2.5 Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . .26
2.6 Methods for Limiting Personal Exposure . . . . . . . . . . . . . .27
2.7 Inventory, Receipt and Storage . . . . . . . . . . . . . . . . . . . . . .29
2.8 Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
2.8.1 Ambient Exposure Rates . . . . . . . . . . . . . . . . . . . .30
2.8.2 Removable Contamination (Wipe Tests) . . . . . . . .31

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vi / CONTENTS

2.8.3 Airborne Activity . . . . . . . . . . . . . . . . . . . . . . . . . . 32


2.9 Personal Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2.9.1 External Monitoring . . . . . . . . . . . . . . . . . . . . . . . 33
2.9.2 Bioassay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2.10 Radioactive Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . 35
2.10.1 Return to Vendor . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.10.2 Storage for Radioactive Decay . . . . . . . . . . . . . . . 35
2.10.3 Transfer to a Radioactive Waste Facility
or Broker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.10.4 Disposal via Sanitary Sewer. . . . . . . . . . . . . . . . . 36
2.11 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2.12 Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2.13 Transport of Patients and Patient Specimens. . . . . . . . . . 38

3. Radiopharmaceutical Therapy . . . . . . . . . . . . . . . . . . . . . . . 40
3.1 Systemic and Regional Therapies . . . . . . . . . . . . . . . . . . . 41
3.2 Choice of Radionuclides . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.3 Clinical Aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.3.1 Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.3.2 Prescription of Administered Activity . . . . . . . . . 49
3.3.3 Assay of Administered Activity . . . . . . . . . . . . . . 50
3.3.4 Acceptance Criteria for Therapeutic
Radiopharmaceuticals . . . . . . . . . . . . . . . . . . . . . 52
3.3.5 Administration of Therapeutic
Radiopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . 53
3.3.6 Addressable Events . . . . . . . . . . . . . . . . . . . . . . . . 55
3.3.7 Considerations in Patient Confinement. . . . . . . . 56
3.3.8 Special Considerations for Female Patients . . . . 57
3.3.9 Heritable Effects and Genetic Counseling . . . . . . 59
3.4 Radiation Safety Procedures . . . . . . . . . . . . . . . . . . . . . . . 61
3.5 Patient-Release Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
3.5.1 Doses to Individuals and Family Members . . . . . 65
3.5.2 Travel by Radiopharmaceutical Therapy
Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
3.6 Emerging Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

4. Brachytherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4.1 Techniques and Basic Terminology . . . . . . . . . . . . . . . . . . 71
4.2 Sources, Delivery Technology, and Dosimetry . . . . . . . . . 74
4.2.1 Specification of Source Strength for Photon
Emitters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
4.2.2 Determination of Absorbed Dose . . . . . . . . . . . . . 78
4.2.3 Physical and Dosimetric Properties of
Brachytherapy Sources . . . . . . . . . . . . . . . . . . . . 81

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CONTENTS / vii

4.2.4 Sources for Low Dose-Rate Intracavitary


Brachytherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
4.2.5 Sources for Permanent Interstitial
Brachytherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
4.2.6 Sources for High Dose-Rate Brachytherapy . . . . .84
4.2.7 Beta-Ray Applicators and Eye Plaques. . . . . . . . .85
4.2.8 Experimental Brachytherapy Sources. . . . . . . . . .85
4.3 Treatment Delivery Technology . . . . . . . . . . . . . . . . . . . . .86
4.3.1 Permanent Implants . . . . . . . . . . . . . . . . . . . . . . .86
4.3.2 Manual Afterloading . . . . . . . . . . . . . . . . . . . . . . .88
4.3.3 Low Dose-Rate Brachytherapy Remote
Afterloading Systems . . . . . . . . . . . . . . . . . . . . . . .89
4.3.4 High Dose-Rate Brachytherapy Remote
Afterloading Systems . . . . . . . . . . . . . . . . . . . . . . .90
4.3.5 “Pulsed” Dose-Rate Remote Afterloading
Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
4.4 Specific Precautions and Procedures . . . . . . . . . . . . . . . . .92
4.4.1 Manual Afterloading . . . . . . . . . . . . . . . . . . . . . . .92
4.4.2 Patient Care Precautions During Treatment . . . .94
4.4.3 Patient Care Precautions During Source
Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
4.4.4 Low Dose-Rate Remote Afterloading. . . . . . . . . . .96
4.4.5 High Dose-Rate Remote Afterloading . . . . . . . . . .97
4.4.5.1 Organization of the Treatment
Delivery. . . . . . . . . . . . . . . . . . . . . . . . . .98
4.4.5.2 Documentation Requirements . . . . . . . .98
4.4.5.3 Treatment Specific Quality-
Assurance Recommendations . . . . . . . .99
4.5 High Dose-Rate Emergency Procedures and Treatment
Attendance Requirements . . . . . . . . . . . . . . . . . . . . . . . . .101
4.6 Addressable Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
4.7 Readmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
4.7.1 Inventory Control . . . . . . . . . . . . . . . . . . . . . . . . .105
4.7.2 General Radiation Safety Procedures . . . . . . . . .105
4.8 Emergency/Off-Hours Response . . . . . . . . . . . . . . . . . . . .106
4.9 Other Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
4.9.1 Intravascular Brachytherapy. . . . . . . . . . . . . . . .106
4.9.2 Other Experimental Applications . . . . . . . . . . . .108
4.9.3 Use of High Dose-Rate Units for Intraoperative
Radiation Therapy . . . . . . . . . . . . . . . . . . . . . . . .109
4.9.4 Balloon Applicators . . . . . . . . . . . . . . . . . . . . . . .109

5. Facility Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111


5.1 General Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . .111
5.1.1 Controlled Areas . . . . . . . . . . . . . . . . . . . . . . . . . .112

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5.1.2 Uncontrolled Areas . . . . . . . . . . . . . . . . . . . . . . . 113


5.1.3 Designation of Occupational Radiation
Employees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
5.1.4 Consideration for Patient Areas . . . . . . . . . . . . . 114
5.2 Brachytherapy Treatment . . . . . . . . . . . . . . . . . . . . . . . . 115
5.2.1 Treatment-Area Design. . . . . . . . . . . . . . . . . . . . 116
5.2.2 Low Dose-Rate Conventional Remote
Afterloading Systems . . . . . . . . . . . . . . . . . . . . . 119
5.2.3 Requirements for Source Preparation and
Storage Room. . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
5.2.4 Low Dose-Rate Procedure Rooms and
Treatment-Planning/Imaging Equipment . . . . . 121
5.2.5 Requirements for High Dose-Rate
Brachytherapy Facilities. . . . . . . . . . . . . . . . . . . 121
5.2.6 Additional Requirements for “Pulsed” Dose
Rate Brachytherapy Facilities . . . . . . . . . . . . . . 126
5.3 Facilities for Unsealed Sources . . . . . . . . . . . . . . . . . . . . 126
5.3.1 Radiopharmaceutical Dispensing
Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
5.3.2 Storage of Low-Level Radioactive Waste . . . . . . 128

6. Changes in Medical Status of the Radioactive Patient . 130


6.1 Cardiac or Respiratory Arrest . . . . . . . . . . . . . . . . . . . . . 130
6.2 Mental Status of the Patient . . . . . . . . . . . . . . . . . . . . . . 131
6.3 Emergency Surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
6.4 Patients on Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
6.5 Transfer to Another Healthcare Facility . . . . . . . . . . . . . 133
6.6 Readmission of Patients to the Treating Institution . . . 134
6.7 Death of the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
6.7.1 Death of the Patient Within a Treating
Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
6.7.2 Removal of Temporary Implants . . . . . . . . . . . . 134
6.7.3 Death of the Patient Outside of the Treating
Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
6.7.4 Organ Donation . . . . . . . . . . . . . . . . . . . . . . . . . . 135
6.7.5 Permanent Implants and
Radiopharmaceuticals . . . . . . . . . . . . . . . . . . . . . 136
6.7.6 Precautions During Autopsy. . . . . . . . . . . . . . . . 136
6.7.7 Preparation for Burial Without Autopsy or
Embalming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
6.7.8 Preparation for Burial by Embalming . . . . . . . . 138
6.7.9 Precautions During Visitation . . . . . . . . . . . . . . 138
6.7.10 Cremation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

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CONTENTS / ix

Appendix A. Patient-Release Criteria . . . . . . . . . . . . . . . . . . . .141


A.1 Dosimetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .141
A.1.1 Physical Quantities . . . . . . . . . . . . . . . . . . . . . . .142
A.1.2 Operational Quantities. . . . . . . . . . . . . . . . . . . . .142
A.1.3 Protection Quantities . . . . . . . . . . . . . . . . . . . . . .143
A.2 Exposed Groups and Dose Limits . . . . . . . . . . . . . . . . . . .144
A.3 Occupancy Factors and Index Distances . . . . . . . . . . . . .146
A.4 Operational Equations . . . . . . . . . . . . . . . . . . . . . . . . . . . .147

Appendix B. Examples of the Application of the


Operational Equations Given in Appendix A . . . . . . . . . .161
B.1 Example 1: Metastatic Thyroid Cancer . . . . . . . . . . . . . .162
B.2 Example 2: Hyperthyroidism. . . . . . . . . . . . . . . . . . . . . . .169
B.3 Example 3: Metastatic Carcinoid Cancer . . . . . . . . . . . . .175

Appendix C. Quality Assurance for High Dose-Rate


Brachytherapy Applications . . . . . . . . . . . . . . . . . . . . . . . . .181
C.1 Treatment-Preparation Checks . . . . . . . . . . . . . . . . . . . . .181
C.2 Applicator Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182
C.3 Implant Localization and Imaging . . . . . . . . . . . . . . . . . .182
C.4 Treatment Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . .182
C.5 Treatment Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
C.6 Pretreatment Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
C.7 Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184
C.8 Setup Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184
C.9 Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185
C.10 Post-Treatment Checks . . . . . . . . . . . . . . . . . . . . . . . . . . .185

Appendix D. Shielding for High Dose-Rate Brachytherapy


Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .186
D.1 General Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187
D.1.1 Occupancy Factor . . . . . . . . . . . . . . . . . . . . . . . . .188
D.1.2 Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .188
D.1.3 Workload . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189
D.1.4 Location of the Treatment . . . . . . . . . . . . . . . . . .190
D.1.5 Source Parameter . . . . . . . . . . . . . . . . . . . . . . . . .191
D.2 Construction Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . .191
D.3 Performance Assessment . . . . . . . . . . . . . . . . . . . . . . . . . .194
D.4 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . .195

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .196

Symbols and Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .202

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x / CONTENTS

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

The NCRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

NCRP Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245

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Executive Summary

This Report is intended for use by a wide readership including


physicians, medical physicists, health physicists, administrators,
nurses, other professional and medical staff, and patients.1 The
approaches originally suggested in NCRP Report No. 37, Precau-
tions in the Management of Patients Who Have Received Therapeutic
Amounts of Radionuclides, are incorporated and updated (NCRP,
1970).
There are aspects of this Report that will, of necessity, touch on
the physician-patient relationship. The requirements to explain
risks from therapeutic procedures and to obtain adequate,
informed patient consent are proper roles of the treating physician
and the institutional review board of the facility involved. It is
within the charge of the institutional review board as defined in
federal regulations to review the propriety and language of consent
forms; to judge the understanding of the content of consent forms
and investigative protocols by the patient, the patient’s representa-
tive or family; and to judge the adequacy of statements about radi-
ation risk. In many facilities, the radiation safety committee (RSC)
is advisory to the institutional review board in making this judg-
ment. A discussion of risks associated with radiation doses and
informed consent is beyond the scope of this Report. Information
about radiation risks is available in NCRP Report No. 115 (NCRP,
1993a) and other publications cited in the references.
NCRP made an arbitrary division between sealed and unsealed
radioactive sources and considered all unsealed sources under the
category of radiopharmaceutical therapy, although some unsealed
source applications will fit the category of device as defined by the
U.S. Food and Drug Administration (FDA). Sealed radioactive
sources are considered in the brachytherapy section. Depending on
the ethos of a particular facility, the lines of this division may blur,
however the particular recommendations would still apply.

1In some parts of the Report, the reader will find both International
System (SI) units and conventional units (e.g., curie). This approach
reflects the current state of medical practice in making the transition to
the SI system in the United States.

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2 / EXECUTIVE SUMMARY

Section 1 of this Report is an introduction and includes some


brief historical items. This Section discusses the basic principles of
both radiopharmaceutical therapy and brachytherapy. Section 2
deals with basic radiation safety principles in a medical facility and
includes a description of the radiation safety program, dose limits,
staffing and definitions specific to this Report. Section 3 addresses
radiopharmaceutical therapy including both clinical and radiation
safety aspects. Appendices A and B expand on the patient-release
criteria outlined in Section 3 and include a spreadsheet program
for assisting in determining patient-release instructions. Section 4
deals specifically with brachytherapy including techniques, termi-
nology, and a brief discussion of applicable dosimetry. Appendix C
presents a discussion of quality-assurance (QA) requirements for
high dose-rate (HDR) afterloading which is an increasingly useful
modality. Appendix D outlines shielding requirements for HDR
brachytherapy installations.
Both Sections 3 and 4 discuss radiation doses and administered
activity levels. The actual activities or radiation doses used for any
individual patient will be prescribed by the treating physician and
may vary considerably from the amounts shown. The radiation
doses or administered activities listed are only an indication of
what may be used. The amounts listed are not a substitute for an
individual prescription, and this Report is not a prescribing man-
ual. Any of the numerical values used for illustration of processes
or examples involved are not recommendations.
Section 5 includes facility design for both nuclear-medicine and
radiation-oncology installations. Section 6 describes changes in
patients’ status, including medical emergencies and presents
guidelines for other situations that may be adapted to readers’
facilities.

Dose Limits

Due to the infrequent nature of potential radiation exposures


and because of the substantial benefits that accrue to the family
from a patient’s treatment, a radiation dose limit of 5 mSv annually
for members of the patient’s family is recommended. This recom-
mendation is consistent with the recommendations of NCRP Com-
mentary No. 11 (NCRP, 1995a).

Patient Confinement

Medical confinement in a hospital or skilled-care facility of a


patient receiving radionuclide therapeutic treatment is intended
to minimize the radiation dose to the public and to members of

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EXECUTIVE SUMMARY / 3

the patient’s family. Such treatment may range from oral ingestion
of a capsule containing radioactive material to emplacement of
sealed sources by a surgical procedure. However, it is recognized
that the presence and support of a patient’s family may contribute
substantially to the therapeutic outcome and improve the patient’s
quality-of-life. The treating physician, in consultation with the
facility radiation safety officer (RSO), will determine the need for
medical confinement. This decision will consider the physical and
mental condition of the patient as well as the individual living
circumstances. It should be possible for the majority of patients to
be treated as outpatients if provided with adequate instructions,
both oral and written, for the patient and his family, for other insti-
tutions with which the patient may interact, and for regulatory
authorities.

Patient Records
Patient records, whether in written or electronic form, should
clearly identify the radionuclide therapy procedure performed
including the radionuclide and activity used as well as the physical
and chemical form, the treating physician, and contact informa-
tion. These records should be maintained in the records of the facil-
ity either permanently or for a time designated by the relevant
regulatory agencies.
NCRP recognizes that there are existing federal or state regula-
tory requirements covering many topics in this Report and the rec-
ommendations in this Report are not intended to supplant these
regulations. These regulations, where applicable, should be con-
sulted in applying the general principles discussed. However,
NCRP considered that it had a broader mandate than to simply
recapitulate regulations. As a particular example, NCRP reviewed
the regulatory definitions of “misadministration” and “medical
events” and chose to define an alternate term, “addressable events,”
that included the regulatory requirements, but expanded consider-
ation to include events that may have systematic implications.
Therefore, addressable events as defined will include events that
could result in patient injury or harm as well as events that have no
associated injury. The intent of the term, addressable events, is to
indicate a broader mandate to examine the cause of an event, sys-
tematic changes as required, and any necessary changes in practice.
The rapid advance of technology and the enlarging field of radi-
onuclide applications will cause some of the specific treatments in
this Report to eventually become outdated. However, the basic
principles discussed and the radiation protection guidelines pre-
sented should remain constant.

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1. Introduction

The treatment of cancer and certain other allied diseases relies


on the use of ionizing radiation or radionuclides in various modali-
ties. The use of high-energy x rays and electrons is reserved to
external-beam radiotherapy (ERT) and the field of radiation oncol-
ogy. Patients treated with ERT do not represent a hazard to staff or
family and are not the subject of this Report. The use of unsealed
radionuclides for radiopharmaceutical therapy falls to the practice
of nuclear medicine. The use of sealed radionuclides for brachyther-
apy falls to the practice of radiation oncology. Together, these fields
form the substance of this Report and are collectively identified in
this Report as radionuclide therapy.
The approaches originally suggested in NCRP Report No. 37,
Precautions in the Management of Patients Who Have Received
Therapeutic Amounts of Radionuclides, are incorporated and
updated (NCRP, 1970). NCRP Report No. 124, Sources and Magni-
tude of Occupational and Public Exposures from Nuclear Medicine
Procedures, discusses the magnitude of occupational and public
exposures from nuclear-medicine procedures and is a companion
report (NCRP, 1996). This Report also incorporates discussions
found in NCRP Report No. 105, Radiation Protection for Medical
and Allied Health Personnel; NCRP Report No. 127, Operational
Radiation Safety Program; as well as recommendations discussed
in NCRP Commentary No. 9, Considerations Regarding the Unin-
tended Radiation Exposure of the Embryo, Fetus or Nursing Child;
NCRP Commentary No. 11, Dose Limits for Individuals Who
Receive Exposure from Radionuclide Therapy Patients; and NCRP
Statement No. 10, Recent Applications of the NCRP Public Dose
Limit Recommendation for Ionizing Radiation (NCRP, 1989; 1994;
1995a; 1998; 2004a). In addition, NCRP Annual Meeting Proceed-
ings No. 19, The Effects of Pre- and Postconception Exposure to
Radiation, and No. 21, Radiation Protection in Medicine: Contem-
porary Issues, cover several specific issues in a comprehensive for-
mat beyond the scope of this Report (NCRP, 1999a; 1999b).
This introduction outlines the principles within which NCRP
framed its recommendations. Of necessity, NCRP could not deal
with every conceivable situation or application. However, the gen-
eral guidelines stated and the overall philosophy presented should

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1.1 BRIEF HISTORY / 5

provide a template for a medical facility seeking to administer ther-


apeutic amounts of radionuclides to patients needing such services
while providing a safe working environment for other patients,
medical staff, family members, visitors, and the public.
Throughout the Report amounts of activity are stated for the
practices or procedures under discussion. This is done only
for illustration purposes and these amounts are not to be taken as
actual prescriptions for the particular practices or procedures. The
prescription of activity for a patient is the sole responsibility of
the prescribing physician.
Terms and symbols used in this Report are defined in the text
and in the Glossary. Recommendations throughout this Report are
expressed in terms of shall and should (in italics) where:

• shall indicates a recommendation that is necessary to meet


currently accepted standards of radiation protection; and
• should indicates an advisory recommendation that is to be
applied when practicable or practical (e.g., cost effective).

1.1 Brief History

It seems appropriate at the beginning of the 21st century to


mention, albeit briefly, some landmarks in the history of therapeu-
tic radiation applications, particularly in view of four recent cen-
tennials (i.e., the 1995 centennial of the discovery of x rays, the
1998 centennial of the discovery of radium, the 2003 centennial of
the award of the Nobel Prize to Marie Curie and Henri Becquerel,
and the 2005 centennial of the publications by Albert Einstein on
the theory of relativity). For those persons wishing to explore this
fascinating history in more depth, a number of references are pro-
vided (Curie, 1938; del Regato, 1985; 1996a; 1996b; Quimby, 1948).
The discovery of x rays by Wilhelm Conrad Roentgen in 1895
appeared in all of the news media of his day (Dam, 1896). In 1896,
Emil Grubbe started radiation treatments for a postoperative
recurrence of breast cancer, the first attempt at radiotherapy any-
where in the world (del Regato, 1996a). Within the first year follow-
ing Roentgen’s discovery, almost 1,000 papers were published on
applications of x rays. The problems of tube design limited early
tubes to the production of x rays with voltages close to 60 kV, suit-
able for treatment in dermatology. In 1914, William D. Coolidge
published his paper describing the first successful roentgen-ray
tube built with a tungsten filament (Coolidge, 1913). This discovery
made possible the use of x rays of the order of 200 kV, so called
“deep therapy.”

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6 / 1. INTRODUCTION

In 1896, the eminent French scientist, Henri Becquerel, first


detected naturally occurring radioactive substances and suggested
that the study of this phenomenon might prove an interesting doc-
toral thesis for Marie Curie. The work of Marie and Pierre Curie
began in a search for the properties of radioactive materials, and
finally resulted in experiments on thorium (Curie, 1938). Testing of
pitchblende ores secured from the mines of Joachimsthal showed
higher levels of activity than were predicted for thorium alone.
Madame Curie’s search for a new element resulted in the discovery
of polonium in 1898, named for her native Poland (Curie, 1938).
Further refinement of this ore resulted in the discovery of a second
radioactive element, radium (Curie et al., 1898). Both discoveries
began to be used immediately in medicine (Curie, 1938; Glasser,
1961).
In 1905, Robert Abbe attempted the first interstitial application
in the United States (del Regato, 1996a). The Pasteur Laboratory
of the Radium Institute at the University of Paris was founded
in 1909. After World War I, the team of George Richard, Jean
Pierquin, and Octave Monod began therapeutic trials to develop
treatment methods for radium (del Regato, 1996a).
Abbe initiated a procedure in which tubes of radium were left
post-operatively in the vicinity of tumors, the predecessor of
modern afterloading techniques (del Regato, 1996a). Radium ore
imported from Africa or Eastern Europe was a scarce and costly
commodity. American mines in Colorado were opened to allow
American hospitals to obtain radium at lower but still significant
costs (del Regato, 1996a). William Duane, who had studied with
Marie Curie in Paris for several years, developed a radium emana-
tion and extraction process. In 1917, Duane installed a radon plant
at the Memorial Hospital in New York City. Radon was captured in
glass capillary tubes that could be cut into sections, “seeds,” to be
brought into contact with tumors (Brucer, 1993). Duane’s methods
were improved upon by Gioacchino Failla, who had also studied
with Marie Curie. Failla’s improvements included placing the
radon into gold capillary tubes, adding the advantage of filtration
(del Regato, 1996a). Claudius Regaud demonstrated experimen-
tally that a moderate total dose of radiation subdivided into frac-
tions and administered in several exposures was more effective
than a single large dose (del Regato, 1996a). Fractionated dose reg-
imens were elaborated by Edith Quimby at the Memorial Hospital
who developed treatment schemes for irradiation (Quimby, 1931;
1935; 1937; 1948). In 1938, only 39 American physicians confined
their practice to therapeutic radiology and most of these physicians
had been self-taught or received training in Europe (del Regato,

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1.2 RESEARCH WITH RADIOACTIVE MATERIAL / 7

1996b). The development of radiation oncology as a specialty is


addressed in several publications, notably the historical articles
published by del Regato (1996a; 1996b). By 1940, commercial x-ray
units of one or two million volts were available in the United
States. However, there were physicians and physicists who favored
the use of radium sources to deliver doses exterior to the body,
so-called teletherapy. A teletherapy unit using 4 g of radium was
installed and built at the Memorial Hospital. However, the clinical
results were not sufficiently impressive to justify continued use.
During the 1930s, Edith Quimby published tables for the calcu-
lation of doses from implants in tissues and investigated the use
of various sources in interstitial therapy (Quimby, 1931; 1935).
Paterson and Parker presented refined calculation systems for
delivering uniform doses to implanted volumes (Paterson, 1934;
Paterson et al., 1936). In 1958, Ulrich Henschke used 192Ir seeds for
temporary implants and began using afterloading techniques
for brachytherapy. Refinements led to the introduction of remote
afterloading in the 1960s (Henschke, 1963). Also, in the 1960s, a
number of radium/radon substitute sources were investigated
and in 1965, the first implant using 125I seeds was performed at
the Memorial Hospital (Hilaris, 1975). In the 1980s, 103Pd seeds
became available and were used for interstitial procedures.

1.2 Research with Radioactive Material

In 1923, George de Hevesy studied plant metabolism with 212Pb


and developed the concept of radioactive tracers. He also performed
the first radioactive trace studies in animals during the following
years and published his results in 1948 (de Hevesy, 1948).
In 1934, Frederic Joliot and Irene Curie published a paper that
described the first chemical proof of artificial transmutation as well
as demonstrating that an alpha particle was captured in these
reactions (Joliot and Curie, 1934). The transmutation of beryllium,
magnesium and aluminum gave birth to new species that emitted
positrons (e.g., 13N). This paper, in <600 words, described the pro-
cess for making these new isotopes that would later have applica-
tion in nuclear medicine. This discovery would bring the authors a
Nobel Prize.
The announcement from the Manhattan Project of the availabil-
ity of large quantities of various artificially-produced radionuclides
ushered in a new era of medical research (Manhattan, 1946).
Cobalt-60 was one of the first radionuclides investigated because of
its relatively long half-life and potential for use in therapeutic
applications (Myers, 1948). Three-hundred shipments of various

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8 / 1. INTRODUCTION

artificial radionuclides were made during the first year of opera-


tion. By 1956, the number of shipments had risen to 15,000 and
5,000 institutions were placing orders (Quimby, 1970).
First produced in minute quantities by George de Hevesy in
1934, 32P, as sodium phosphate, became an obvious therapeutic
choice to treat a variety of neoplasias when Ernest Lawrence’s
cyclotron at the University of California, Berkeley, could produce
significant quantities of the radionuclide (de Hevesy, 1948).
Ernest’s brother, a physician, John Lawrence, reported partial
responses to 32P in chronic myelogenous leukemia by 1938,
while Lowell Erf and others at Berkeley found 32P effective in treat-
ing polycythemia vera by 1941. Meanwhile a joint program at
Massachusetts General Hospital and the Massachusetts Institute
of Technology, begun in 1937, focused on radioiodine for thyroid dis-
eases. The first radioiodine produced, in April 1937, was 128I, which
had a very short half-life, <30 min, but allowed for basic physiolog-
ical studies. The progress by Glenn Seaborg and John Livingood at
Berkeley to discover longer-lived iodine radioisotopes was rapid,
and the first article on 131I, with an 8 d half-life, appeared only
30 months later, in October 1939. In two more years a patient had
been scanned for metastases from thyroid cancer with radioiodine,
but World War II caused a hiatus in research with medical uses of
radionuclides. In 1946, Samuel Seidlin announced the first cure
of thyroid cancer with 131I. In the decade following the end of World
War II, iodine labeling of human albumin allowed study of the
blood pool and detection of brain tumors, iodinated rose bengal was
used to study liver physiology and anatomy, and radioiron produc-
tion led to detailed studies of erythropoiesis.
At the University of California Berkeley, Ernest Lawrence
designed the first cyclotron and produced radionuclides by bom-
bardment with accelerated particles (Lawrence, 1934; 1936).
Lawrence received the Nobel Prize in 1939 for this development.
The use of cyclotrons for radionuclide production reduced the
dependence on reactor-produced sources and allowed for the pro-
duction of short-lived positron-emitting radionuclides and other
radionuclides not made in reactors.
The development of the molybdenum/technetium generator in
the 1970s provided the stimulus for the synthesis of many new
radiopharmaceuticals. The production of the parent element, 99Mo,
was a reactor-based operation, but the availability of the short-
lived 99mTc decay product allowed larger activities to be adminis-
tered to patients with lower radiation doses compared to previously
used radionuclides. Technetium-99m labeled compounds replaced
older tracers such as 203Hg and 197Hg for renal studies and the use

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1.3 PRINCIPLES OF RADIOPHARMACEUTICAL THERAPY / 9

of 198Au colloid for liver imaging. By the end of the 20th century,
~80 % of diagnostic nuclear-medicine procedures were performed
with 99mTc.
In the late 1960s, the availability of cyclotrons small enough to
be placed in medical centers made possible the exploration of the
use of positron-emitting isotopes such as 18F, 11C, and 15O for diag-
nostic nuclear-medicine studies. The full diagnostic capabilities of
positron-labeled pharmaceuticals, such as 18F-fluorodeoxyglucose,
in the fields of neurologic and oncologic imaging were finally real-
ized in the 1990s due to improvements in imaging technology. The
use of 18F-fluorodeoxyglucose, a tracer of glucose metabolism, to
measure localized increase in glucose metabolism has provided a
unique insight into the detection and staging of a variety of cancers
(Hustinx et al., 1996).

1.3 Principles of Radiopharmaceutical Therapy

The major objective of radiopharmaceutical therapy has been to


maximize the uptake and retention of activity in a target organ,
especially an organ containing a tumor, while minimizing the
uptake of activity in normal tissue. Tissue uptake and retention is
controlled by the chemical and physical properties of the radiop-
harmaceutical. Therapeutic radiopharmaceuticals are employed in
anticipation of a selective tumoricidal effect on the target tissue. As
opposed to ERT where the radiation must pass through some nor-
mal tissue, the orally or intravenously administered radiopharma-
ceuticals currently employed have a relatively selective uptake in
malignant tissue. Among the essential properties of therapeutic
radionuclides are charged particle emissions (e.g., alpha or electron
emissions), a high ratio of charged particle to photon energy abun-
dance, and if possible, a physical half-life substantially longer than
the exponential or nearly exponential rise of the administered
activity in a particular organ or tissue and substantially shorter
than the biological half-life of the radiopharmaceutical in the tar-
get tissue. These properties are intended to increase the ratio of
radiation dose delivered to the target tumor to the radiation dose
received by the rest of the body. The majority of therapeutic radiop-
harmaceuticals in use today emit beta particles of sufficient energy
to traverse many layers of tumor cells adjacent to the deposition of
the pharmaceutical. For micrometastases, radionuclides that emit
Auger electrons with relatively short path lengths or alpha parti-
cles that can traverse two or three cell diameters before dissipating
their energy may be desirable. Criteria for radionuclide selection
are discussed in Section 3.

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10 / 1. INTRODUCTION

Radionuclide localization techniques have involved approaches


such as the use of hormone receptors (e.g., somatostatin) tumor
antigens of varying specificity reacting with labeled antibodies;
and uptakes of radiotracers that are incorporated into specific
physiological processes [e.g., sodium iodide (Na131I)]. Several
approaches have been attempted to reduce uptake in nontarget tis-
sue. These approaches have involved enhancing excretion from the
bladder, bowel and salivary glands in order to markedly reduce
radiation toxicity to these organs. Other techniques involve the
administration of nonlabeled pharmaceuticals, so-called blocking
doses, that are intended to prevent uptake in the primary site that
is not the object of the treatment and, therefore, force the radiop-
harmaceutical to be concentrated in a secondary site.

1.4 Principles of Brachytherapy

The name, brachytherapy, derives from the Greek prefix,


“brachys,” meaning short, literally therapy at short distances. The
term is generally understood to mean the placement of sealed
sources within or adjacent to a treatment site. This technique
requires that the area to be treated be accessible and that the
tumor be geometrically limited and be of small to moderate size.
Access will generally involve some type of surgical intervention.
The tumor will be subjected to continuous irradiation to a total pre-
scribed therapeutic dose for as long as the sources are present.
Brachytherapy may be the primary treatment or be an adjunct (i.e.,
a “boost”) to ERT.
Sealed sources may be left in place permanently, as in intersti-
tial seed implants, or placed temporarily and removed after a pre-
scribed treatment time, such as in intracavitary treatment.
Determination as to whether a radionuclide is suitable for perma-
nent or temporary use is usually a function of the half-life of the
source. In general, 125I with a half-life equal to 60 d is the longest
lived radionuclide used for permanent implants. In temporary
implantation, sources may be placed within an applicator that has
been placed in a body cavity, within catheters that have been placed
in or around a tumor, and plaques placed on the skin or mucosal
surface. Criteria for source selection are discussed in Section 4.
The most frequent use of temporary implantation is for the
treatment of gynecological tumors. The techniques initially devel-
oped for gynecological applications involved the use of applicators
into which the sealed sources had been loaded prior to placement,
so-called “preloaded” applications. The applicator, loaded with

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1.4 PRINCIPLES OF BRACHYTHERAPY / 11

sealed sources, was brought to the operating room. The loaded


applicator was placed within the body cavity and manually manip-
ulated into the correct position by the physician. A technique was
also available for placement of sealed sources within the uterine
cavity, a technique known as Heyman packing. This technique
relied on manual positioning of the sources. Both of these tech-
niques involved doses to everyone within the operating room and
recovery areas and resulted in large doses to the treating physi-
cian, typically a surgeon or gynecologist. These techniques were
replaced in the period from the 1960s to the 1970s by afterloading
techniques in which sources are positioned at some time following
the placement of the source holder, typically a catheter. In after-
loading, there are no doses received by the surgical or recovery staff
because the sealed sources are positioned after the surgical inter-
vention and treatment plan. The treating physician was typically a
radiologist or radiation oncologist.
Another brachytherapy technique involves the placement of
sources, either permanently or temporarily, within interstitial
spaces. For temporary implants, sources were fashioned into nee-
dles for direct insertion into tissue or placement in catheters dur-
ing a surgical procedure. One of the first radionuclides used for
seed implantation was 222Rn. These seeds were manufactured by
the capture of radon gas in gold seeds. Another early technique
intended to replace the use of radon seeds involved the use of 198Au
seeds, originally called gold grains to distinguish these seeds from
the 222Rn seeds (Sinclair, 1952). The accumulated therapeutic expe-
rience prior to 1960 relied on the use of radium and radon sources.
The use of radium-substitute sources, such as 60Co or 137Cs, became
possible after reactor-produced sources became available. In the
1960s, 192Ir sources were introduced and techniques using these
sources remain in current use (Henschke, 1963). Temporary inter-
stitial treatment techniques using high-specific activity sources of
125
I [i.e., 185 to 1,850 MBq (5 to 10 mCi)] were developed because
their use offered significant radiation protection advantages. How-
ever, due to cost, these sources have not found wide acceptance.
Interstitial techniques may involve the permanent placement of
small sealed sources, “seeds,” within the tumor itself. The seeds are
introduced into tissue using either needle placement or “guns” that
can place multiple seeds along a plane within the tumor volume
(Hodt et al., 1952). The most common use of this technique is in
prostrate brachytherapy with the seeds implanted through the
perineum under imaging guidance. The possible radiobiological
advantages of various techniques and sources have been discussed
(Ling, 1992).

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12 / 1. INTRODUCTION

In brachytherapy, a small volume of tissue can be treated at


dose levels higher than the doses delivered by conventional exter-
nal-beam techniques. The isodose lines exhibit a higher dose gradi-
ent and, therefore, the treatment volume needs to be carefully
defined. In a certain sense, brachytherapy techniques represent
the ultimate in conformal therapy. Many of the techniques
described in Section 4 involve some surgical intervention, which
may not be suitable for all patients.

1.5 General Considerations

Radiopharmaceutical therapy and brachytherapy should be


specifically planned for each individual so that therapeutic objec-
tives are achieved with minimum irradiation of both the patient
and hospital personnel. It is the responsibility of the treating phy-
sician (e.g., the nuclear-medicine physician or radiation oncologist)
to ensure that all pertinent information is available so that the
therapeutic procedure can be justified and optimized. Available
information should include consideration of alternative treat-
ments, the risks and relative efficacy of all treatments, and also the
impact of radiopharmaceutical therapy and brachytherapy, includ-
ing medical confinement and post-release radiation precautions, on
the overall well being of the patient. Patients and families should
be provided with informational materials that are both comprehen-
sive and easy to understand. Where appropriate, such materials
should also be available for non-English speaking populations. If
there is a choice of radiopharmaceuticals available for a therapy
procedure, the relative merits of the chemical, biological and phys-
ical properties of each pharmaceutical in terms of reduction of radi-
ation risks should be considered. Availability, relative costs, and
other logistical issues may also affect the treatment decision.
Patient age and lifestyle-related issues will influence the con-
sideration of treatment modality. For example, for a younger per-
son wishing to start a family in the near or distant future, the
possible consequences of significant gonadal irradiation incidental
to radiopharmaceutical therapy or brachytherapy should be con-
sidered and discussed with the patient. The long-term reproductive
consequences of high activity radionuclide therapy as well as any
possible short-term impairment of fertility following such therapy
may be of concern to the patient. In women of childbearing age, the
possibility of pregnancy at the time of treatment and the justifica-
tion for the procedure shall be carefully and explicitly considered.
Whether female patients are breastfeeding small children shall
also be explicitly considered for radiopharmaceutical therapy.

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1.5 GENERAL CONSIDERATIONS / 13

The pediatric patient is also of special concern, not only because


of the generally greater radiation sensitivity of rapidly dividing
cells but also because of the longer period of risk for radiogenic
sequelae following therapy. While radiopharmaceutical therapy or
brachytherapy in children is relatively rare, such therapies may
well be critical for the patient. The biological distribution, metabo-
lism and excretion of radiopharmaceuticals vary widely with age,
and differences are most pronounced in infancy and old age. There-
fore, age-dependent dosimetry models should be used in planning
radiopharmaceutical therapy.
For all therapeutic administrations, an appropriate entry shall
be made in the patients’ medical records which includes the date
and time of therapy, the activity used and the identity of the radio-
nuclide. For radiopharmaceutical therapy, this information shall
also include the radiopharmaceutical and the date and time of
assay. Medical facilities undertaking any form of therapy involving
the therapeutic applications of radionuclides shall have a QA pro-
gram in place. The details of these programs and specifics of radio-
nuclide administrations are discussed in the following sections.

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2. Radiation Safety
Program in a Medical
Facility

This Section describes the controls (administrative, procedural


and engineered) necessary for a radiation safety program in a med-
ical facility that utilizes therapeutic quantities of radionuclides.
The discussion provided in this Section is not intended to cover
all situations encountered in every type of medical facility. It
should be considered as guidance to assist the facility in developing
its own procedures and QA program. Additional guidance may be
found in other NCRP reports and International Commission on
Radiological Protection (ICRP) publications (ICRP, 1983; 1989;
NCRP, 1983; 1989; 1995b; 1998). Various scientific organizations
have addressed topics covered in this Report and have published
task group reports or specific guidance. These organizations
include, among others, the American Association of Physicists
in Medicine (AAPM), American College of Radiology, American
College of Medical Physics, Health Physics Society, and the Society
of Nuclear Medicine. A number of these reports are included in the
references of this Report. However, a complete listing may be found
on the websites of the various organizations.

2.1 Description of the Radiation Safety Program

Medical facilities that use sealed and unsealed radioactive


sources for therapeutic purposes shall have a radiation safety pro-
gram. The program shall be commensurate with the hazards asso-
ciated with use of the radioactive sources and shall adequately
protect workers and the public. Prior to the use of any radioactive
source, facility management or an appropriate physician or physi-
cist shall consult with a qualified expert2 to evaluate the potential
radiation hazards and to develop appropriate elements of the radi-
ation safety program. The radiation safety program shall be

2Qualified expert is defined in the Glossary and the sections that


follow.

14

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2.2 CURRENT DOSE LIMITS AND RADIATION PROTECTION GOALS / 15

reviewed annually to confirm that it continues to meet the opera-


tional objectives of the facility, the recommendations of appropriate
standards and the requirements of federal, state and local regula-
tions. The annual review shall be conducted by a qualified expert
who has similar program experience. The qualified expert for these
activities may be an individual who works for the facility or an out-
side expert. The program shall include appropriate policies, prac-
tices and equipment to maintain radiation exposures to workers
and the public as low as reasonably achievable (ALARA), social and
economic factors being taken into account.
A facility Radiation Safety Officer (RSO) shall be designated
to fulfill the responsibilities described in Section 2.3.2. In small
programs the RSO may be a physician or physicist knowledgeable
in radiation safety practice. The qualifications for the RSO will
depend on the size and complexity of the facility, but the RSO shall
have appropriate education, training and experience to adequately
address the needs of the program. Large, complex practices should
consider requiring the RSO to be certified by a specialty board such
as the American Board of Health Physics, the American Board of
Medical Physics, the American Board of Radiology, or the American
Board of Nuclear Medicine. The RSO should seek advice from other
qualified experts, as necessary, whenever the facility considers use
of a new modality or new radiation source that has characteristics
different from those currently in use.

2.2 Current Dose Limits and Radiation


Protection Goals

2.2.1 Recommended Dose Limits

Current radiation protection standards are based on the


assumption that any radiation dose above natural background may
create some additional risk of damage, particularly cancer. Radia-
tion protection is concerned with the total detriment from radiation
exposure, which includes fatal and nonfatal cancers, hereditary
defects, and potential life-span shortening. Thus, it is prudent to
design a radiation safety program that maintains radiation doses
to workers and the public ALARA.
The 1977 report of the United Nations Scientific Committee on
the Effects of Atomic Radiation (UNSCEAR) was the first report in
a series to provide risk estimates for cancer in a number of organs
(UNSCEAR, 1977). The risk estimates were derived from a variety
of studies but relied primarily on the data from the Japanese
atomic-bomb survivors. The 1988 UNSCEAR report, the tenth in

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16 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

that series, revised the estimates from the 1977 report and consid-
ered excess cancer mortality as the major factor to be used in set-
ting radiation protection standards (UNSCEAR, 1988). In 1990, the
National Academy of Sciences/National Research Council (NAS/
NRC) issued the Biological Effects of Ionizing Radiation (BEIR V)
report (NAS/NRC, 1990) which updated earlier estimates of both
the somatic and genetic effects of radiation and incorporated the
estimates from the UNSCEAR (1988) report. Rates of mortality
from various forms of cancer were analyzed in relation to age at
irradiation, sex, time after irradiation, and other variables. In 2006,
NAS/NRC issued BEIR VII (NAS/NRC, 2006) to update BEIR V
using new information from epidemiologic and experimental
research that accumulated since the 1990 review (NAS/NRC, 2006).
NCRP Report No. 91 (NCRP, 1987), now superseded by Report
No. 116 (NCRP, 1993b), was the first in a series of reports that
based radiation exposure limits on risk estimates. NCRP Report
No. 115 (NCRP, 1993a) reviewed the risk estimates for radiation
protection in light of the UNSCEAR (1988) report and BEIR V
(NAS/NRC, 1990) report. This report provided the theoretical basis
for the recommendations published in NCRP Report No. 116
(NCRP, 1993b). These recommendations for limitations of radiation
exposure were established at a level to achieve the objectives of
radiation protection (i.e., prevention of the occurrence of clinically
significant acute radiation damage and limitation of the risk of sto-
chastic effects) such as cancer and genetic effects, and of determin-
istic effects, such as cataract induction. The risk estimates for
radiation protection are discussed in NCRP Report No. 115 (NCRP,
1993a). These recommended limits for occupational dose and dose
to members of the public are shown in Table 2.1 and exclude radi-
ation doses received by an individual as a patient and doses from
natural background radiation including radon. The risk associated
with exposure to radiation doses within these limits is considered
to be very small. However, it is assumed that increase in risk is pro-
portional to dose; thus, NCRP recommends that the radiation
safety program shall be designed to keep radiation doses ALARA.
The specific objectives of radiation protection as stated in NCRP
Report No. 116 are:

• prevention of the occurrence of clinically significant radia-


tion-induced deterministic effects by adhering to dose limits
that are below the apparent threshold levels; and
• limitation of the risk of stochastic effects, cancer and genetic
effects, to a reasonable level in relation to societal needs,
values, benefits gained, and economic factors.

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2.2 CURRENT DOSE LIMITS AND RADIATION PROTECTION GOALS / 17

TABLE 2.1—Recommended dose limits.

Annual Effective Dose Limit (mSv)

Adult workersa 50

Adult worker who declares her pregnancya 0.5 mSv month–1

Members of the publica 1

Family member of patientb 5

Pregnant women and childrenb 1

Trained and monitored family member of


patientb 50

Adult lifetimea Age × 10 mSv


a
This Table affirms the recommendations of NCRP as published in Report
No. 116 (NCRP, 1993b). Although these recommendations may be incorporated
into regulation, they are not necessarily exactly the same as the dose limits that
may be found in federal or state regulations (NRC, 1988). The references pro-
vided in the various sections of this Report may provide additional guidance.
bNCRP Commentary No. 11 and Statement No. 10 (NCRP, 1995a; 2004a).

NCRP Report No. 116 recommends that:

• any activity that involves radiation exposure shall be justi-


fied on the basis that the expected benefits to society exceed
the overall societal cost (justification);
• the total societal detriment from justified activities or prac-
tices shall be maintained ALARA, economic and societal fac-
tors being taken into account; and
• individual dose limits shall be applied to ensure that the
procedures of justification and ALARA do not result in indi-
viduals or groups of individuals exceeding levels of accept-
able risk (limitation).

2.2.2 Specific Definitions

This Section provides some specific definitions used in later sec-


tions of this Report. Some of these definitions are specific to the
medical care environment and others are defined in terms of a gen-
eral understanding of the application of societal concepts within
the medical environment. A Glossary is included in this Report for
further information.

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18 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

For purposes of limiting radiation doses, members of a patient’s


family should be considered as distinct from members of the public.
However, for pregnant women and children who may be family
members, the public limit would still apply. Typically, when a
patient is diagnosed with a potentially life-threatening disease,
such as cancer, the patient as well as members of the family are
deeply affected. In such cases, judgments on the benefits to the
patient and the family from family interactions need to be consid-
ered in the decisions on radiation protection standards.
A “family member” is any person who provides support and com-
fort to a patient on a regular basis and is considered by the patient
as a member of their “family” whether by birth or marriage or by
virtue of a close, loving relationship.
In some cases involving radiopharmaceutical therapy or brachy-
therapy, the patient shall be confined for purposes of radiation
protection following the administration or emplacement of radioac-
tive sources. This confinement shall take place within a “medical
facility.”
A “medical facility” is a hospital, clinic or other facility that may
practice radiopharmaceutical therapy or brachytherapy and that
provides in-patient care. This definition specifically excludes the
patient’s own home.
A radiopharmaceutical is any radioactive material in various
forms that is administered to a patient via various routes so that
the material is metabolized by the patient for distribution to vari-
ous organs or tissues or the whole body for purposes of therapy. A
radiopharmaceutical most often includes a radionuclide chemically
bound to a reagent or carrier that localizes the radionuclide in spe-
cific organ systems or local lesions.
Members of the public, such as visitors to a medical facility may
be in the vicinity of patients receiving radiation therapy. A “mem-
ber of the public” is any adult person (i.e., a person >18 y of age) not
a member of the patient’s family and not an individual exposed to
radiation in the course of their employment as a result of the care
and management of the patient.
Whether in written or electronic (computerized) form, a medical
record, treatment folder or “chart” of a patient is the permanent
institutional document in a medical facility that fully describes the
medical history and care of the patient. Pertinent information
regarding radionuclide therapy, including the identity and amount
of radioactive material, date and time of administration, and the
nature and projected duration of radiation precautions shall be
included in the medical record. In addition, any measurements or
calculations for determining the time post-administration at which

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2.2 CURRENT DOSE LIMITS AND RADIATION PROTECTION GOALS / 19

the patient may be released from medical confinement and for post-
release precautions should be included as part of the medical
record.

2.2.3 Dose Limits for Patients’ Families and the Public

The prospects of medical treatment, pain and suffering and


even death of a family member create anxiety and stress within a
family. At such times a family will tend to draw closer together to
provide emotional and physical support to the patient. Family
members often spend additional time with the patient, especially if
treatment is palliative rather than curative. Measures to restrict
access to a patient may be met with resistance by both patient and
family, especially if they extend beyond a few days and are prescrip-
tive, such as confinement in a medical facility. Access restrictions
and confinement may heighten anxiety and stress of both patient
and family. Accordingly, the ALARA principles outlined previously
require that radiation protection standards applied to patients’
families not be as restrictive as those standards for the public. This
principle was first stated in NCRP Report No. 37 (NCRP, 1970) and
is confirmed in this Report. Because radiation treatments are
events that occur no more than a few times, or more likely once in
the course of a lifetime, exposure of patients’ families from radionu-
clide therapy should be considered as an “infrequent” exposure
with an effective dose limit of 5 mSv (NCRP, 1993b). In addition, a
member of a patient’s family may be permitted to receive up to
50 mSv y–1 on the recommendation of the treating physician. When
family members are likely to receive exposures >5 mSv annually,
they should receive training and individual monitoring (NCRP,
1995b). The recommendation of the treating physicians shall be
recorded in the patient record. Pregnant women and children shall
not exceed 1 mSv y–1.
For the purpose of applying radiation exposure limits, members
of the public include other patients, visitors to the medical facility,
such as family members of other patients in the facility, and staff
who are not specifically trained in radiation safety. Other patients
confined in the medical facility may be unintentionally exposed to
patients receiving radionuclide therapy. The usual source of this
exposure is occupancy of a room immediately adjacent to a patient
receiving therapy. The effective doses to persons who have no famil-
ial connections to the patient and for whom there is no emotional
benefit shall be limited to 1 mSv y–1. Special considerations for
women are included in Sections 3 and 4 of this Report and may be
found in NCRP Commentary No. 9 (NCRP, 1994).

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20 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

Some patients may be released while still containing measur-


able amounts of activity. Patients should be transported using
a private car. Mass transit should not be used if an individual
passenger or transit worker could receive >1 mSv annually. Co-
workers who come into contact with a patient treated with radioac-
tive sources should not receive an annual radiation dose >1 mSv.
The doses to children or pregnant members of the family shall not
exceed 1 mSv y–1. Toward this end, facilities should ensure that
family members clearly understand the appropriate precautions.
Application of this limit is discussed further in Section 3 of this
Report.

2.2.4 Personal Monitoring and Bioassays

Many aspects of this Report focus on the patient under treat-


ment. However, there is also the potential for significant occupa-
tional doses to staff who treat or care for the patient. The
monitoring of doses to radiation workers is the subject of NCRP
Report No. 122 (NCRP, 1995b). For staff who do not prepare radiop-
harmaceutical or brachytherapy sources, a single dosimeter worn
on the trunk is usually sufficient. Staff who prepare radiopharma-
ceutical or brachytherapy sources, especially those for therapy,
usually use localized shielding to protect the trunk of the body. For
those persons, monitoring of the dose to the extremities, forearms
or other critical organs may require using additional dosimeters.
The RSO shall consider the specific personal monitoring needs
of persons preparing therapeutic amounts of radiopharmaceuticals
or sealed sources for use in brachytherapy. NCRP Report No. 122
provides additional guidance for this situation. The program shall
provide authority to enforce the use of personal monitoring devices.
The results of personal monitoring may require interpretation and
should be left to the judgment of the RSO. Monitored staff shall be
made aware of personal monitoring results at appropriate frequen-
cies determined by the RSO, both as a safeguard for their own
health and to provide an opportunity for the worker to make sug-
gestions on maintaining doses ALARA.
Certain radiopharmaceutical therapies may require that staff
prepare or use radioactive sources that have a volatile component.
The classical example of this is the use of 131I sodium iodide.
In these cases, the RSO shall establish a bioassay program consis-
tent with regulatory requirements and complexity of the program
at the facility. The use of closed preparation systems and specific
ion-exchange column preparations shall be considered to minimize
the doses received by staff. The use or availability of properly

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2.3 STAFFING / 21

ventilated hoods shall be part of an ALARA program for volatile


materials. The design of an operational radiation safety program is
discussed in NCRP Report No. 127 (NCRP, 1998).

2.3 Staffing

The staffing of medical facilities varies reflecting the patient


load, the complexity of the practice, the research and education
programs and, to some extent, the culture of the facility. The
descriptions below are meant to provide a basis for considerations
of the type of staffing necessary to conduct a program as well as to
provide some guidance to management.

2.3.1 Physician

Radioactive sources shall be administered to patients by or


under the supervision of a physician who possesses a license to
practice medicine and who is qualified by appropriate training and
experience. U.S. Nuclear Regulatory Commission (NRC) or Agree-
ment States promulgate requirements that define the training and
experience required for various categories of radioactive source
administrations, both diagnostic and therapeutic. Physician spe-
cialists, such as ophthalmologists or cardiologists, may meet the
requirements of various licensing subcategories as defined by
the regulations. These specialists are usually restricted to a spe-
cific type of application, such as use of radioactive eye plaques or
the placement of radioactive cardiac stents, respectively. For the
purposes of this Report, the larger groupings of nuclear-medicine
physicians or radiation oncologists are considered.
Typically, the nuclear-medicine physician and the radiation
oncologist, by virtue of training and education, experience, and
professional credentials, including certification and licensure, have
the ultimate responsibility for the planning, delivery and follow-up
of patients undergoing radiopharmaceutical therapy or brachy-
therapy. This responsibility includes the protection of the patient,
facility personnel, visitors, and other individuals from unnecessary
radiation exposure. Although consultation with referring physi-
cians is necessary in the planning of such therapies, the nuclear-
medicine physician or the radiation oncologist shall make the ulti-
mate decisions regarding such therapies. In larger facilities, one or
more of these specialists should serve on the Radiation Safety Com-
mittee (RSC) of the medical facility and provide consultation to the
Committee as necessary. In facilities with emergency departments,
the nuclear-medicine physician or radiation oncologist may also
serve as the designated radiation emergency physician.

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22 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

The responsibilities of the nuclear-medicine physician and


the radiation oncologist include, in consultation with the RSO, the
determination of whether medical confinement of patients for radi-
ation protection is required. The formulation of radiation precau-
tions for the staff of the medical facility and for visitors, as well as
the formulation of and advice given to the patient and to members
of the patient’s family regarding post-release radiation precau-
tions, including the duration of such precautions, is the responsibil-
ity of the RSO.

2.3.2 Radiation Safety Officer


In any medical facility in which radiation or radioactive sources
are used a radiation safety officer (RSO) shall be designated who
will have the responsibility to establish and the authority to
enforce policies and procedures concerning safety and regulatory
compliance in the use of radioactive sources (NCRP, 1998). Facility
management shall empower the RSO with the necessary institu-
tional authority to enforce such polices and procedures, including
termination of the use of radioactive sources, and enable the RSO
to have direct access to facility executive management. The train-
ing and experience of the RSO shall be commensurate with the
complexity of the program and may be specified by a regulatory
authority according to the type of licensure required by the pro-
gram. These specifications may include certification by appropriate
professional organizations (e.g., American Board of Health Physics,
American Board of Radiology, or American Board of Medical
Physics).
Several states have enacted licensure laws that require that
medical physicists be licensed. In some of these states, persons
practicing the subspecialties of medical physics, including medical
health physics, shall be specifically licensed. Licensure laws for
medical physicists are pending in other states. Facilities in states
with licensure laws should ensure that the physicists practicing in
their facility are licensed or practicing under the supervision of a
licensed physicist. In facilities with limited programs (e.g., clinics
limited to routine diagnostic uses of radiopharmaceuticals) it may
be acceptable for a radiologist certified by the American Board of
Radiology or a nuclear-medicine physician certified by the Ameri-
can Board of Nuclear Medicine to be appointed as the facility RSO.
Some of the duties of the RSO include:

• determination of radiation doses received by occupationally-


exposed individuals and the public in and around the medi-
cal facility;

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2.3 STAFFING / 23

• promulgation of procedures for minimizing radiation expo-


sure of such individuals;
• specification of precautions to be followed by patients
treated with therapeutic amounts of radioactive sources;
• education and training of staff;
• education and training of the patient and the patient’s fam-
ily on post-release precautions;
• disposal of radioactive waste;
• removal of radioactive contamination;
• inventory and receipt of radioactive sources;
• consultation on shielding design;
• supervision of procedures that ensure the accuracy of the
quantities of the administered radionuclides; and
• service on the RSC.

The RSO need not personally perform these duties and may del-
egate them to appropriately trained persons. However, when such
delegations are made, the RSO shall be responsible for ensuring
that the duties are performed correctly. Throughout this Report,
any reference to the radiation safety officer (RSO), includes that
individual and any authorized designees such as radiation safety
staff.

2.3.3 Medical Physicist and Nuclear Pharmacist

For any program utilizing radioactive sources for therapeutic


purposes, the services of a medical physicist shall be available
on-site either on a full- or part-time basis. A qualified medical phys-
icist shall be responsible for the supervision of the quality-control
(QC) program in brachytherapy. For programs in nuclear medicine,
a qualified medical physicist, a qualified nuclear pharmacist, or a
nuclear-medicine physician should supervise the QC programs. For
programs in nuclear medicine, the qualified nuclear pharmacist
should perform a drug regimen review as required by state phar-
macy regulations and the Joint Commission on Accreditation of
Health Care Organizations. For facilities with programs in both
nuclear medicine and brachytherapy, the services of medical phys-
icists specializing in those areas will be necessary. The professional
training and experience required of the medical physicist shall be
commensurate with the complexity of the program and should
include specialty board certification by appropriate professional
organizations.
The duties of the medical physicist should include:

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24 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

• calibration of equipment used for the assay of activity;


• calibration of brachytherapy sources;
• development of treatment plans;
• QC of nuclear-medicine imaging equipment;
• patient dosimetry;
• supervision of dosimetrists; and
• supervision of technologists.

The duties of a qualified nuclear pharmacist should include:

• assessing each patient’s medication related needs;


• performing a patient drug regimen review prior to the ther-
apeutic administration;
• procuring and dispensing of therapeutic radiopharmaceuti-
cals;
• assaying the radioactive dosage;
• performing QC of the equipment used for the assay of
activity;
• ensuring that the drug is of acceptable quality, purity and
strength;
• ensuring that the radiopharmaceutical is compounded
according to the specifications; established by the U.S. Phar-
macopoeia (USP, 2004a);
• ensuring that the therapeutic radiopharmaceutical is pre-
pared in the proper dosage form for the specific patient use
(e.g., capsule, injection, suspension or solution); and
• ensuring that considerations for pediatric dosing are
reviewed and appropriate.

2.3.4 Radiation Therapist and Nuclear-Medicine Technologist

In many facilities using radioactive sources, there will usually


be radiation therapists, formerly called radiation-therapy technol-
ogists, and nuclear-medicine technologists, the number of each will
depend on the size of the program. These individuals will have
undergone a period of training specified by professional registries
or state licensing programs. Their responsibilities include assisting
the radiation oncologist or nuclear-medicine physician in the deliv-
ery of the radioactive materials. The specific role of the radiation
therapist in HDR remote afterloading is discussed in Section 4 and
Appendix B. In nuclear-medicine applications, the technologist pre-
pares the computerized data in a format suitable for interpretation
by the nuclear-medicine physician. Depending on the program in

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2.3 STAFFING / 25

specific facilities, nuclear-medicine technologists may also assist


in the radiopharmacy and may dispense and may inject radiophar-
maceuticals into patients.

2.3.5 Dosimetrist

Larger radiation-oncology programs employ the services of med-


ical dosimetrists to assist the physician and medical physicist in
the preparation and evaluation of treatment plans. These persons
will have undergone a period of training under a qualified medical
physicist and radiation oncologist and should have professional
certification. The role of the dosimetrist in certain brachytherapy
applications is discussed in Section 4 and Appendix B.

2.3.6 Nurse

Nurses who are specially trained in caring for patients treated


with therapeutic amounts of radionuclides may be assigned to full-
or part-time duty in nuclear medicine, radiation oncology, or a
nursing unit that provides care for radionuclide therapy patients.
These individuals should receive training by the authorized user
and RSO that is more detailed than training provided to other
nursing groups. Historically, nurses have played a variety of roles
in these areas including the preparation of applicators and sealed
sources for patient procedures in radiation oncology. In more recent
times, the role of the nurse has evolved into a clinical support role
for the radiation oncologist and nuclear-medicine physician. The
duties of the nurse may include evaluation of the mental and phys-
ical status of the patient, injection of diagnostic doses of radiophar-
maceuticals, making the physician aware of unusual or aberrant
symptoms or events, and assistance in patient emergencies.

2.3.7 Physician-in-Training

Some facilities may sponsor physician residency training pro-


grams. Larger facilities may also sponsor specialty fellowships in
subspecialty areas such as brachytherapy. The physicians enrolled
in these programs are licensed to practice medicine, and have
elected to pursue a radiological specialty. Specialty certification
boards require that these physicians acquire skills that will involve
the administration of radioactive materials to patients. An experi-
enced specialist physician shall supervise these physicians during
their training period and should be on the premises during the
administration of therapeutic quantities of radioactive materials
to patients. The specialist physician or the RSO shall train

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26 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

fellows and residents in emergency procedures, regulatory require-


ments, and radiation safety procedures.
Teaching hospitals may provide opportunities for medical stu-
dents to rotate through certain specialties or subspecialties, includ-
ing the subspecialties of radiology. Although these students will not
be involved in the administration of radioactive materials, they
may be present when radioactive materials are administered. The
role of these students and the requirements for supervision shall be
clearly defined in the hospital procedure manuals. The require-
ments for monitoring shall be defined by the RSO as part of the
radiation safety program.

2.4 Radiation Safety Committee

A medical-radiation facility, where therapeutic quantities of


radionuclides are administered, shall have a standing radiation
safety committee (RSC) that shall include at a minimum the RSO,
a representative of management, a nurse and other individuals
including physicians who have background and experience in
radiation safety and the utilization of radiation and radioactive
material. In large programs, the RSC should also include represen-
tatives with expertise in areas such as nuclear medicine, radiation
oncology, nuclear pharmacy, radiation physics, and biomedical sci-
ences. The RSC shall meet at regular intervals to review the rou-
tine and investigative uses of radioactive materials, to review the
facility’s radiation safety program, to review specific radiation
safety questions or events, and to review institutional policy. The
frequency of meetings required will depend on the complexity of
the program. Special meetings should be convened as necessary by
the Chair or at the request of the RSO and written minutes of all
meetings shall be maintained. For certain medical-radiation facili-
ties a RSC may not be necessary and may be replaced by knowl-
edgeable professionals authorized by the management of the
facility to develop and oversee its radiation safety program.

2.5 Management Commitment

Management shall be involved in the oversight of the QA and


radiation safety programs of the facility. The involvement includes
the allocation of resources adequate to meet the needs of the pro-
gram and participation in the activities of the RSC. These alloca-
tions should be considered along with the requirements of
regulatory authority. There should be direct communication
between the RSO and facility management to promptly address the

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2.6 METHODS FOR LIMITING PERSONAL EXPOSURE / 27

needs of the program. Facility management shall provide the RSO


with sufficient resources, authority and autonomy to implement
the radiation safety program.
The management of medical facilities and other installations in
which ionizing radiation is employed shall have specific written
policies and procedures for establishing and complying with
dose-limiting standards (NCRP, 1998; NRC, 2005). These policies
and procedures are usually derived from recommendations of advi-
sory bodies such as NCRP or regulations promulgated by govern-
mental agencies in the form of laws, codes and licensing guides. An
important component of the radiation safety program of any such
installation is a formal ALARA policy and procedure such as
described in NCRP Report No. 107 (NCRP, 1990). It is not sufficient
for a medical facility simply to maintain personal exposures below
recommended or regulatory limits. A facility shall have a written,
proactive policy and procedure to formally and practically maintain
personal exposures ALARA. A medical facility performing radionu-
clide therapy shall be prepared to provide adequate resources,
financial and otherwise, to comply with personal exposure limits
and the ALARA principle.

2.6 Methods for Limiting Personal Exposure

Sections 3 and 4 discuss specific precautions to be taken during


radiopharmaceutical therapy and brachytherapy. This Section out-
lines general precautions and provides an overview of radiation
protection techniques. Methods for limiting personal exposure in
radiation installations can be classified as either physical (or engi-
neered) safeguards, including instrumentation, or as procedural
controls (NCRP, 1998). Physical safeguards include all devices used
to restrict access of staff and other individuals to radiation sources
or to reduce radiation levels. Section 5 of this Report deals with
facility design.
Procedural controls include instructions to and formal training
of personnel regarding performance of their duties in a specific
manner for the purpose of limiting radiation exposure. Details of
such controls should be incorporated into institutional or depart-
mental policies and procedures (NCRP, 1989; 1998). Regularly
scheduled periodic radiation monitoring of occupationally-exposed
personnel and in the work areas is necessary to ensure the ade-
quacy of and compliance with physical safeguards and established
procedural controls.

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28 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

Procedures for handling radioactive materials shall conform to


good radiation safety practice. Personnel working with unsealed
radioactive sources shall wear disposable gloves and appropriate
protective clothing, such as laboratory coats or disposable gowns.
Personal dosimeters shall be worn when working with beta-,
photon- and neutron-emitting radionuclides or in areas where
radiation-producing equipment is present when potential doses
warrant them. When working with large quantities of pure beta-
emitting radionuclides, thermoluminescent dosimeters such as
ring badges may be required. The necessity for monitoring and cri-
teria for the monitoring program shall be part of the radiation
safety program. To the extent possible, unsealed radioactive
sources should be handled on plastic-backed absorbent pads and
paper behind shielding as necessary. The amount and type of
shielding necessary should be determined in consultation with the
RSO. Eating, drinking, smoking, mouth pipetting, and other tech-
niques that have the potential for accidental inhalation or inges-
tion of radioactive materials shall be forbidden in areas where
radioactive materials are used. Applying cosmetics, handling con-
tact lenses or other personal items have the potential to transfer
radioactive materials to the exterior surface of the skin or other
areas. These actions shall be forbidden in areas where radioactive
materials are used. Laboratory coats and some form of eye protec-
tion (e.g., safety glasses or splash guards) shall routinely be worn
when handling radioactive materials in a pharmacy setting.
Radiopharmaceuticals and brachytherapy sources shall be
transported in shielded containers if warranted by the amount of
activity. The shielding of these containers should conform to the
ALARA principles, and consultation with the RSO on appropriate
shielding may be necessary. Protective equipment listed above and,
including disposable gloves and shielded syringes shall be used
during the administration of radiopharmaceuticals. The necessity
of other protective equipment (e.g., safety goggles, shoe covers)
should be reviewed by the RSO. Impermeable absorbent materials
such as plastic-backed absorbent pads should be placed under-
neath an injection or infusion site.
Consistent with patient safety and good quality medical care,
personnel should spend as little time as necessary near or around
radioactive material or patients treated with radiopharmaceuticals
or brachytherapy sources, and should remain at distances as deter-
mined from exposure-rate measurements from such patients.
Whenever practicable, in consultation with the RSO, portable
shielding should be used to reduce further radiation levels to staff,
especially during the hospitalization of radioactive patients.

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2.7 INVENTORY, RECEIPT AND STORAGE / 29

2.7 Inventory, Receipt and Storage

If radioactive materials are packaged and shipped according to


regulatory standards, the potential for inadvertent exposure is
minimal. It is rare that a package is damaged during shipment suf-
ficient to cause a radiation hazard. Packages containing radioac-
tive sources should be delivered directly to the radiation safety
office or to the brachytherapy or nuclear-medicine facility, received
by an authorized individual in that facility and surveyed and
secured upon arrival as outlined below.
In some instances delivery of radioactive sources may occur
when the brachytherapy or nuclear-medicine facility is closed and
there is no member of that facility available to receive the delivery.
A written procedure approved by the facility’s management shall be
in place for off-hour deliveries. This procedure should include infor-
mation for the facility’s security or other approved personnel to gain
access to the brachytherapy, nuclear medicine, or other appropriate
secured area for receipt and storage of deliveries. Packages contain-
ing radioactive sources shall not be left unattended or unsecured.
Packages containing radioactive sources shall be examined and
opened with the use of disposable gloves and other protective cloth-
ing. Packages shall be inspected immediately upon receipt for any
sign of damage such as breakage, moisture or discoloration of the
outer packing. As soon as possible after receipt, packages shall be
monitored for external radiation levels using a radiation survey
meter. Surface contamination should be determined by wipe test-
ing. If the measured exposure rate is not consistent with the pack-
age label, if the removable surface contamination exceeds action
levels established by the RSO, or if it appears that the package is
damaged, the RSO or designee shall be contacted immediately.
Once a package is opened, the inner container should be inspected
for any breakage or leakage. The inner container should be wipe
tested for contamination. The inner container label and the pack-
ing slip should be cross-checked to verify the vendor, the identity
and physical and chemical forms of the radionuclide, the activity
present, and date and time of calibration. Any deviations shall be
discussed with the vendor and resolved before the material is used.
These data shall be recorded in the facility’s records. The packing
material and empty packages shall be monitored for radioactive
contamination using a survey meter before disposal. If radioac-
tively contaminated, these materials shall be treated as radioactive
waste. If free of contamination, the radiation/activity labels shall
be removed or obliterated before disposal of the packaging as non-
radioactive waste.

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30 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

All vials or other vessels that contain radioactive materials


shall be labeled with “caution radioactive material” labels. Such
labels shall provide the identity of the radionuclide, physical or
chemical forms of the radionuclide, activity, and date and time of
calibration. Items that contain significant quantities of activity
shall be stored in shielded containers, typically made of lead
because the volumes are not large, with a thickness of shielding
appropriate to the radionuclide and total activity present. Contain-
ers should be stored on plastic-backed absorbent pads, in shielded
cabinets or drawers or behind lead or lead and low atomic-number
combination shields (e.g., lead acrylic). For certain radiopharma-
ceuticals that must be stored at low temperatures, a refrigerator
may be lined with lead or a refrigerator may be located in an appro-
priately shielded area. Radioactive materials shall be stored in
secured, controlled areas, such as a radiopharmacy or “hot lab,”
conspicuously posted with “caution radioactive material” warning
signs. If personnel inside these areas could receive a dose of
0.05 mSv in any 1 h, the door shall be posted with a “caution radi-
ation area” sign. These areas require appropriate security. A secu-
rity expert should be consulted to ensure that security objectives
are met. It may be advisable or necessary to require that persons
entering these areas wear protective clothing such as a laboratory
coat and a personal dosimeter for entry. All such controlled areas
shall be regularly monitored for ambient radiation levels and radio-
active contamination. Items such as food, beverages and medica-
tions shall not be stored in the same area as radioactive materials.

2.8 Surveys

The following sections outline some of the types of surveys that


may be necessary in a program that utilizes therapeutic quantities
of radioactive materials. These discussions are, of necessity, generic
and should be supplemented with a specific program designed by
the RSO.

2.8.1 Ambient Exposure Rates

A suitable radiation survey meter shall be available to measure


ambient exposure or air kerma for calculation of absorbed dose or
dose-equivalent rates. Such devices shall provide measurement in
roentgen, rad, gray, rem or sievert per unit of time. The limits of
measurement and characteristics of survey meters vary widely. It
is critical to match the type of survey meter used with the charac-
teristics of the radiation being measured. This will be particularly
important in the measurement of low-energy radiations such as the

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2.8 SURVEYS / 31

emissions from 125I and radionuclides with similar energies.


The most common types of devices for measurement of exposure
rate are the Geiger-Mueller (GM) counter and the ion chamber
(St. Germain, 1995). The limitations of pulse-rate detectors in the
measurement of exposure rates should be understood by the person
performing the survey. Scintillation probes are high-sensitivity
solid-state detectors. The sensitivity of the crystal will be specified
for a range of photon energies. These detectors may be particularly
useful for monitoring of low-energy photons with energies <60 keV.
The ionization chamber, GM counter, scintillation probe with thin
entrance windows, or other radiation detection instrument should
be calibrated to provide readings in appropriate units if measure-
ments of exposure, absorbed dose, or dose equivalent are to be per-
formed. Because of the limited penetration of beta particles and
other particulate radiations, the ability of each type of survey
meter to detect these radiations should be clearly understood. The
use of beta shields or caps may allow for measurements in fields of
mixed radiations. Survey meters should include a “battery check”
function. Survey meters should be checked for proper functional
operation immediately prior to use with a low activity “check
source,” which can be an integral part of the instrument. These
devices shall be calibrated at least annually and records of the cal-
ibrations shall be maintained. Performance standards for radiation
surveys can be found in the recommendations of the American
National Standards Institute (ANSI, 2001).
Properly calibrated ionization chambers, GM counters, and
other survey meters can measure exposure rates at a point in air.
Conversion of these measurements to absorbed dose and dose
equivalent requires several calculational steps. However, for pho-
tons <1 MeV, absorbed dose and dose equivalent are approximately
equal to measured exposures at the corresponding point in air
(Appendix A.1). For beta particles with energies <3 MeV, the
absorbed dose and dose-equivalent rates to skin may be similarly
equated with the measured exposure rate at the corresponding
point in air. These simplifying assumptions are conservatively safe,
and overestimate the actual absorbed dose and dose equivalent
corresponding to a measured exposure rate in air because the sub-
stantial reduction achieved by an irradiated individual’s body is
ignored.

2.8.2 Removable Contamination (Wipe Tests)


Radioactive contamination in the work environment that is
removable can deposit on the skin or enter the body and irradiate
an individual internally. Therefore, assay of removable radioactive

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32 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

contamination on all potentially contaminated surfaces and on


sealed radioactive sources shall be performed at regular intervals
and whenever contamination is suspected. Nonremovable radioac-
tive contamination (i.e., fixed contamination) contributes only to
external exposure and its contribution is incorporated in the deter-
mination of ambient exposure rate. Assay of removable radioactive
contamination is typically performed using a “wipe test.” In such a
test, a representative area of ~100 cm2 of a potentially contami-
nated surface is wiped with a dry or wet material (e.g., filter paper)
and the wipe is counted in a counting system appropriate to
the radioactive materials being used (e.g., a liquid scintillation
counter). The choice of which wipe material to use, the presence or
absence of water or any solvent on a wipe should be discussed with
the RSO to optimize the information obtained. The resulting gross
count rates are converted to net count rates by subtracting a back-
ground, or blank, count rate. Net count rates are converted to activ-
ity by adjusting the count rate by the system counting efficiency for
the radionuclide in question. Results shall be recorded and
archived. Records shall be maintained for periods established by
regulatory agencies or for periods established by the facility, which-
ever is longer (NCRP, 1992a).
Surfaces notably susceptible to radioactive contamination
include doorknobs, drawer handles, light switches, toilet seats and
bathroom fixtures in patient rooms, telephones and telephone
mouthpieces used by patients, and computer keyboards. If remov-
able contamination is detected by wipe testing, the contaminated
surface(s) shall be decontaminated by appropriate techniques.
The decontamination techniques should minimize the spread of
contamination over a larger area. Any radioactively contaminated
disposable items (e.g., gloves and paper toweling) shall be held
for decay in storage or otherwise disposed of as radioactive waste.
Following decontamination, the contaminated area should be wipe
tested again and, if detectable removable contamination is still
present, decontamination should be repeated until levels
approaching background are attained. However, the RSO can
establish institutional levels of removable contamination below
which no further decontamination is required.

2.8.3 Airborne Activity

The most common source of airborne activity in medical practice


is the use of any of the radioisotopes of iodine (e.g., 125I or 131I). Vol-
atilization is most likely to occur when sealed vials of acidic solu-
tions containing radioiodide (sodium iodide) are first opened and

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2.9 PERSONAL MONITORING / 33

when peptides or proteins, including antibodies, are radioiodi-


nated. Radioiodinations shall be performed in closed systems or in
a fume hood equipped with an iodine-trapping filter, such as an
activated charcoal filter. The exhaust shall be vented to a suitable
exhaust stack approved for this purpose by the RSO. The filter
shall be replaced according to the manufacturer’s recommended
schedule or when the pressure gradient across the filter falls below
an acceptable level. The flow rate through the fume hood shall be
measured at least annually. In large programs evaluation of radio-
active releases shall be performed at least annually. Real-time
stack monitoring should be performed in systems such as medical
cyclotrons used for production of short-lived radionuclides. The
design of such systems should be reviewed by an expert in air mon-
itoring systems.
Measurement of radioactive contamination in air can be per-
formed by drawing air through a suitable filter using a vacuum
pump and measuring the activity retained on the filter. An air
pump capable of pumping from 10 to 40 ft3 min–1 and sampling
times from 5 min to 2 h should be used to obtain a reasonable sam-
ple in a short time. A calibrated flow meter is required to measure
the volume of air pumped per unit time.

2.9 Personal Monitoring

2.9.1 External Monitoring

Personal monitoring for external exposure shall be performed


for all occupationally-exposed individuals who, in the judgment of
the RSO, have the potential to receive >10 % of the annual effective
dose limit during the normal course of their duties and individuals
who enter high radiation areas. Facilities shall use personal radia-
tion dosimeters from vendors that are accredited by the National
Voluntary Laboratory Accreditation Program. Extremity dosime-
ters shall be worn when an individual’s extremities are expected to
be closer to the source than the body and could likely exceed 10 %
of the dose limit.

2.9.2 Bioassay

The term bioassay refers to the radiological analysis of:

• the entire body in a whole-body radiation-detection system;


• a portion of the body using an external collimated radiation
detector to determine activity content in a specific area or
organ (e.g., the thyroid);

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34 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

• body fluids (e.g., saliva, sputum, blood);


• excreta (e.g., urine, feces, exhaled breath, or perspiration);
and
• tissue samples (e.g., hair, fingernail parings).

Bioassay is used to determine the activity present in an individual.


The optimal type of bioassay procedure to use depends on the chem-
ical and physical form of the radioactive material, the radiation
emissions, mode of entry of activity into the body, and the charac-
teristic biodistribution and effective half-lives in vivo. Performance
criteria for radiobioassays including statistical testing, reporting of
results and record retention have been established by ANSI (1996).
By application of appropriate biological models and kinetic param-
eters, bioassay measurements are converted to body or organ activ-
ity burdens and, ultimately, to estimates of absorbed dose. Whether
inhaled, ingested, absorbed through intact skin or passed through
breaks in the skin, soluble radioactive materials will be transferred
over time to excreta, particularly urine. This process will rely on
blood transport and can be detected and measured by radioassay ex
vivo of urine or blood samples in a scintillation well counter or liq-
uid scintillation counter.
Internal radioactive contamination from photon emitters may
be detected and measured by total or partial body counting using a
variety of organ uptake probes. Unless internal radioactive con-
tamination is substantial, a gamma camera may not have suffi-
cient sensitivity for bioassays. Removing the collimator and using
the gamma camera in a counting (i.e., nonimaging) mode may pro-
vide adequate sensitivity if the background counting rate is not
excessively high. High resolution gamma-ray spectrometers may
be useful if the identity of the radionuclide is in question.
In radiopharmaceutical therapy, possible internal contamina-
tion can occur from ingestion of liquids or contact of a radiolabeled
compound with bare skin. In a rare circumstance, an individual
may accidentally inject a portion of a compound into his own body
while preparing the radiopharmaceutical. Reporting requirements
for accidental exposures and procedures for bioassay and estimates
of any dose received should be a part of the institution’s policy and
procedure manual.
During the radiochemical labeling of compounds with 131I or 125I,
significant intakes can occur due to the oxidation of radioactive
iodine and the volatilization and inhalation of the radioiodine as a
gas (I2). The rapid uptake and long retention of radioiodine by the
thyroid requires a sensitive bioassay of internal radioiodine con-
tamination. Thyroid burden should be measured using a thyroid

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2.10 RADIOACTIVE WASTE DISPOSAL / 35

uptake probe. Personnel who prepare or administer therapeutic


amounts of radioiodine as well as personnel who radiolabel pep-
tides and proteins with significant amounts of radioiodine should
be monitored as part of an established thyroid bioassay program.
There may be regulatory requirements for a thyroid bioassay pro-
gram and the RSO should advise on these requirements. For
nuclear-medicine personnel involved in therapeutic procedures,
these assays should take place typically within 1 to 3 d after the
administration.

2.10 Radioactive Waste Disposal

Radiopharmaceutical therapy generates low-level radioactive


waste, mostly in the form of dry waste, including empty vials,
syringes, intravenous tubing, disposable gloves, absorbent pads,
paper toweling, gauze, contaminated disposable eating utensils,
and partially decayed radioactive fiducial markers and calibration
sources. Brachytherapy procedures may generate small amounts of
radioactive waste, however these wastes may be longer-lived than
radiopharmaceutical wastes (e.g., spent 125I seeds). Depending on
the volume of radioactive waste generated and the medical facil-
ity's capacity for waste storage, disposal may be accomplished by
one of the methods described in the following subsections.

2.10.1 Return to Vendor

Partially decayed radioactive fiducial markers and standard


calibration sources, especially larger sources, should be returned to
the vendor for disposal. Some vendors will accept seeds containing
radioactive materials that were intended for use in brachytherapy
procedures but were not used. Whenever possible, seeds should be
returned to the vendor. However, when this is not possible, seeds
will have to be held for decay or disposed as low-level radioactive
waste. Commercial radiopharmacies will often accept their
unit-dose syringes and unit- and multi-dose vials used for thera-
peutic radiopharmaceuticals. Vendor acceptance of such items
should be confirmed explicitly before purchase and any disposal
costs specified at the time of purchase, because vendors may not
otherwise accept them.

2.10.2 Storage for Radioactive Decay

Radionuclides that will decay to background levels within a rea-


sonably short period of time (e.g., several months to a few years)

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36 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

may be stored for decay. The volume of radioactive waste that can
be stored on-site will depend on storage capacity within the facility.
Such locations should be in a low-occupancy, secure, and posted
area of the facility and adequately shielded as required. Prior to
disposal or recycling of decayed radioactive waste, such materials
shall be monitored with a suitable survey meter in a low back-
ground area to verify that the activity is acceptably low or not
detectable, and all “radioactive material” labeling shall be removed
or obliterated prior to disposal or recycling. Disposal or recycling of
these materials must meet applicable regulatory requirements.
The RSO should be consulted regarding any disposal requirements.
Lead containers used for storage or shipment of radioactive mate-
rials should be surveyed by wipe testing and with a survey meter
to verify the absence of removable activity and recycled according
to applicable environmental regulations.

2.10.3 Transfer to a Radioactive Waste Facility or Broker

Radioactive waste that cannot be returned to the vendor or that


has a physical half-life beyond that which practically allows on-site
decay in storage may be transferred to a licensed commercial facil-
ity or broker. The identity, amount and chemical/physical form of
the radionuclide(s) shall be specified on the shipping manifest, and
packaging and transport regulations shall be understood by the
licensed shipper. The regulations for shipping and transport are
complex and may also require an understanding of the chemical or
biological hazard in the waste as well as the activity. Transport of
radioactive waste in interstate commerce is governed by the regu-
lations of the U.S. Department of Transportation, NRC, and other
agencies claiming jurisdiction (DOT, 2006). It is, therefore, impor-
tant that the person preparing wastes for shipment be familiar
with these regulations by receiving training in these areas.
The ultimate disposal of these materials will rely on techniques
employed at the disposal site. Volume reduction (e.g., supercompac-
tion or incineration) should be considered to reduce the overall vol-
ume of the waste.

2.10.4 Disposal via Sanitary Sewer

Excreta (including excreta collected in urine bags and bedpans)


from patients who were administered radiopharmaceuticals
should be discharged through the sanitary sewer. After disposal of
liquid patient waste in this manner, the toilet should be flushed
several times and the surfaces rinsed thoroughly with a gentle

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2.11 TRAINING / 37

stream of water to avoid aerosolization or splashing of radioactively


contaminated liquid. Disposal of other forms of radioactive liquid
waste (e.g., from laboratories that do not generate chemical haz-
ards or biological waste) should rely on sufficient dilution of the
waste at the point of disposal and shall be documented and
recorded as part of the institution’s overall program. The RSO shall
ensure that liquid radioactive waste, excluding patient excreta, dis-
charged into the sewer does not exceed regulatory limits and shall
record each disposal.

2.11 Training

Training is an essential component of the radiation safety pro-


gram in a medical-radiation facility. Well-trained staff are essential
in implementing the radiation safety program and in presenting a
positive, competent image to patients. All employees, including
technical, clinical nursing, and support personnel, involved with
patients who contain radioactive materials shall attend a facil-
ity-specific radiation safety program or complete equivalent online
training. The exact content of this training should be tailored by
the RSO to the level of involvement of the staff and their potential
for radiation exposure. Training of such personnel should occur as
soon as possible after new employees begin work. Refresher train-
ing should be provided annually, or whenever there are significant
modifications of an operational procedure that may, in the judg-
ment of the RSO, affect radiation exposure to employees or mem-
bers of the public. Training content should include the nature of
activity, the medical uses of radiation and radioactive materials,
limitations on exposure time and proximity to radiation sources,
use and the limitations of physical safeguards, waste handling pro-
cedures, applicable regulatory requirements, prohibited activities
and other procedural controls and emergency procedures (NCRP,
1989; 2000). Training content should emphasize practical issues
that affect radiation exposure and should be tailored to the specific
tasks performed by personnel. A description of the training mate-
rial and documentation of completion of training shall be retained.
Whenever possible, didactic training should be supplemented by
supervised practical training (i.e., on-the-job training) specific to
the tasks performed by the person being trained.

2.12 Record Keeping


Documentation provides evidence of the reliability and effec-
tiveness of a radiation safety program. Records shall be main-
tained for periods established by regulatory agencies or for periods

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38 / 2. RADIATION SAFETY PROGRAM IN A MEDICAL FACILITY

established by the facility, whichever is longer (NCRP, 1992b;


1995b; 1998). Among the records that should be maintained as part
of the overall program are:

• radioactive materials receipt, inventory, distribution and


disposal, including radiopharmaceutical prescriptions
and brachytherapy written directives;
• radiation survey data, including measurements of ambient
radiation levels and surface radioactive contamination
including facility diagrams indicating the sites of such
measurements;
• airborne activity data;
• radioactive effluent data;
• monitoring records for all occupationally-exposed personnel,
including bioassay data as appropriate;
• written policies and procedures for the radiation safety
program;
• radiation safety training program, including the curriculum
or lesson plans and attendance lists;
• RSC membership and minutes; and
• reports of unusual, radiologically significant occurrences
and operational failures.

2.13 Transport of Patients and Patient Specimens

The movement within a facility of patients treated with diag-


nostic levels of radiopharmaceuticals or specimens from such
patients represents a minimal level of radiation exposure for
employees, patients, and members of the public. However, thera-
peutic quantities of radioactive materials in patients may cause
increased exposure. Radiation doses will be a function of the activ-
ity remaining in the patient, the type and energy of the emitted
radiation, the distribution of the radioactive material within
the patient’s body, the distance from the patient, the time spent
in the vicinity of the patient and, in the case of certain radionu-
clides, the size (thickness) of the patient. When it is deemed neces-
sary to administer radionuclide therapy on an inpatient basis,
therapeutic quantities of radioactive materials should be adminis-
tered in the patient’s room to minimize the need for transportation
of a radioactive patient. Once the therapeutic activity is adminis-
tered, the patient shall remain in the hospital room except in emer-
gencies (e.g., the need for surgical intervention). The advice of the
RSO should be sought for any special precautions (Section 6).

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2.13 TRANSPORT OF PATIENTS AND PATIENT SPECIMENS / 39

Specimens from patients treated with temporary implants of


sealed radioactive sources (e.g., patients with temporary gynecolog-
ical implants) are not radioactive and may be transported without
regard to activity. Urine specimens from patients treated with per-
manent implants (e.g., 125I seeds for prostate implants) may occa-
sionally contain a seed. These specimens should be checked for the
presence of a seed before being sent to the appropriate laboratory.
Specimens from patients treated with radiopharmaceutical ther-
apy may contain activity. It is usually not necessary to shield these
specimens except when a large number of such specimens are
stored in one location. In most cases, standard precautions will
suffice for the handling of these specimens. The RSO should be
consulted any time there are questions.

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3. Radiopharmaceutical
Therapy

Radiopharmaceutical therapy is the administration of unsealed


radioactive material designed to elicit a therapeutic response as a
result of internal irradiation of a target tissue. Therapeutic radio-
pharmaceuticals may be structurally simple (e.g., ions) or complex
materials into which the radioactive material has been incorpo-
rated (e.g., monoclonal antibodies). Such radiopharmaceutical
formulations may be solutions or colloidal suspensions with admin-
istration either systemic or local.
Historically, radioiodine (131I) therapy of thyroid disease, includ-
ing hyperthyroidism as well as localized and metastatic thyroid
cancer, has been the most studied and successful application of
radiopharmaceutical therapy. This success has largely resulted
from the high and rapid uptake and long retention of iodide in thy-
roidal tissue, and little uptake in extra-thyroidal tissues. Although
131I therapy of thyroid disease remains the most widely used form

of radionuclide therapy, there are a number of newer and less


frequently applied radionuclide therapies (Cheung et al., 2001;
Freeman and Blaufox, 1989; 1992; Harbert, 1987; Kramer and
Cheung, 2001; Lashford et al., 1988; Spencer, 1978).
Systemic therapies include:

• targeted radioimmunotherapy of cancer, particularly of leu-


kemias and lymphomas;
• 32P therapy of myeloproliferative diseases, especially poly-
cythemia vera;
• meta-131I-iodobenzylguanidine therapy of neuroendocrine
cancers including pheochromocytomas and neuroblasto-
mas; and
• palliation of bone pain secondary to skeletal metastases
using bone-seeking radiopharmaceuticals such as 32P, 89Sr,
90
Y, 186Re and 188Re, hydroxyethylidene diphosphonate, 153Sm
ethylenediamene tetramethylene phosphonate, 117mSn, and
diethylene triamine pentaacetic acid (DTPA).

Local/regional therapies include:

40

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3.1 SYSTEMIC AND REGIONAL THERAPIES / 41

• intracavitary radioimmunotherapy and radiocolloid therapy


of malignant effusions and ascites using beta emitters such
as 32P;
• intra-cystic radiocolloid therapy, principally using 32P-
chromic phosphate (e.g., cystic intracranial tumors);
• intrathecal radioimmunotherapy and radiocolloid therapy of
leptomeningeal tumors (e.g., 131I-labeled 3F8 monoclonal
antibody);
• intra-articular radiocolloid therapy, also known as radiation
synovectomy, synoviorthesis, or synoviolysis, of benign joint
disease using 51Cr, 186Re, 90Y as citrate or silicate, 153Sm-
hydroxyapatite, and 169Er citrate; and
• intracranial infusion of labeled materials to treat residual
disease following removal of the primary brain tumor (e.g.,
125I labeled organic compounds for treatment of glioblas-

toma multiforme).

3.1 Systemic and Regional Therapies

In systemic therapy, a therapeutic radiopharmaceutical is


administered either orally or parenterally, typically intravenously,
for distribution throughout the patient's entire body via circula-
tory, secretory, metabolic and excretory processes. In this way, some
activity is deposited in all tissues of the body. Each tissue irradiates
and is irradiated by all other tissues of the body. Significant
amounts of activity may be found in all bodily fluids such as blood,
saliva, cerebrospinal fluid, and breast milk as well as in excreta
(e.g., feces, urine, perspiration and breath). In general, blood and
urine contain the larger amounts of activity, especially in the first
several days following administration. Also, radioactive small mol-
ecules (i.e., molecular weight <50,000 dalton) that are not localized
in target tissues will be rapidly excreted by the kidneys. However,
some renal or hepatic localization may occur as a result of metabo-
lism or transchelation. Large molecules, such as radiolabeled pro-
teins and antibodies, are more pharmacokinetically complex.
Although small polar metal chelates typically result in low hepatic
uptake and biliary excretion, protein-bound chelates may enter
hepatocytes and be catabolized to small molecules that subse-
quently may be excreted into the intestines or partially retained. In
systemic therapy with photon-emitting radionuclides, there exists
a significant radioactive contamination hazard from the radioac-
tive excretions as well as an external irradiation hazard to individ-
uals in the vicinity of the patient.

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42 / 3. RADIOPHARMACEUTICAL THERAPY

In regional therapy, the therapeutic radiopharmaceutical is


introduced directly into a specific volume of the body, such as the
pleural cavity, to mechanically deposit activity into the volume or
on the surface of target organs. In this way, specificity of treatment
is maximized. If little or no leakage of the radiopharmaceutical
from the target tissue volume occurs, there is little or no activity in
body fluids or excreta and, therefore, no significant contamination
hazard. In the absence of significant biological clearance, the only
means of elimination of activity is physical decay in situ. Therefore,
the external irradiation hazard in regional therapy can persist
longer than in systemic therapy.
With the continued development of new radiopharmaceuticals,
management of patients who have received therapeutic amounts of
radionuclides is becoming increasingly important and complex. A
compilation of the properties of photon- and beta-emitting radionu-
clides commonly used in therapeutic radiopharmaceuticals is pre-
sented in Table 3.1.

3.2 Choice of Radionuclides

Selection of the optimal radionuclide is clearly critical to suc-


cessful therapy. While it is difficult to generalize, dosimetric consid-
erations can provide guidelines for the selection of appropriate
therapeutic radionuclides (Hosain and Hosain, 1978; Spencer,
1978; Wessels and Rogus, 1984; Zanzonico et al., 1995). If possible,
the physical half-life of the radionuclide should be substantially
longer than the uptake half-time and substantially shorter than
the clearance half-time of the radiopharmaceutical in the target
tissue. In this way, the amount of time the activity remains in the
tissue and, therefore, the absorbed dose to the target tissue will be
maximized while the dose to nontarget tissues will be minimized.
In regional therapy, these considerations will not apply. Radiobio-
logical considerations suggest that therapeutic radionuclides with
excessively long physical half-lives may be undesirable (Ling,
1992). In practice, however, long-lived radionuclides may prove to
be therapeutically effective.
Because self-irradiation (i.e., dose from activity in the target tis-
sue) generally represents the largest component of total absorbed
dose in a target region, a therapeutic radionuclide should emit
principally nonpenetrating (beta, alpha) radiation and little or no
photon (x or gamma ray) radiation. To a first-order approximation,
this corresponds to maximizing the ratio of the nonpenetrating to
photon equilibrium dose constants. The nonpenetrating radiation

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TABLE 3.1—Physical properties of photon- and beta-emitting radionuclides commonly used in
therapeutic radiopharmaceuticals.
Specific Specific Bremsstrahlung Constanta,b
Maximum (R cm2 mCi–1 h–1)
Physical Gamma-Ray
Radionuclide Beta-Ray Energy
Half-Life Constanta,b Soft Tissue Bone (calcium)
(MeV)
(R cm2 mCi–1 h–1) Zeff = 7.9 Zeff = 21
Photon- and Beta-Emitters
131
I 8.04 d 2.23 0.81 0.000768 0.00204
177
Lu 6.7 d 0.222 0.497, 0.44 0.000385 0.00102
153
Sm 47 h 0.712 0.8 0.000597 0.0.00159
186
Re 89 h 0.143 1.07 0.00121 0.00322
188
Re 17 h 0.320 2.12 0.00154 0.00409
Beta-Emitters
32
P 14.3 d — 1.71 0.00405 0.0108
33
P 25.4 d — 0.25 0.000658 0.00175
89
Sr c 50.5 h — 1.49 0.00314 0.00843
90
Y 64.1 h — 2.28 0.00564 0.015
a 177
Values for constants from NUREG-1556, Vol. 9 (NRC, 2005), and, for Lu only (Unger and Trubey, 1982).
bThe
specific gamma-ray constant is a physical quantity that is expressed in conventional units of R cm2 mCi–1 h–1. The specific
3.2 CHOICE OF RADIONUCLIDES

gamma-ray constant and the analogous specific bremsstrahlung are, therefore, expressed in these conventional units.
c
Although 89Sr emits a gamma ray, it is grouped with the beta emitters because the frequency of its gamma-ray emissions, <0.01 % per
decay, is negligibly low.
/ 43

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44 / 3. RADIOPHARMACEUTICAL THERAPY

must nonetheless be sufficiently energetic to actually irradiate tar-


get cell nuclei, the critical radiobiologic target within the cell
(Warters et al., 1977). It is often desirable in practice that a radio-
nuclide either itself emit photons in sufficient abundance and of
suitable energy for external imaging or have an isotope that emits
such radiations. For example, 85Sr, which emits a 514 keV gamma
ray, may be used as an imaging surrogate of the pure beta-emitter
89Sr (Footnote c in Table 3.1), a radionuclide of strontium used ther-

apeutically (Blake et al., 1988; Breen et al., 1992). Other radionu-


clides emit only high-energy beta particles (e.g., 32P with average
energy 0.70 MeV) and there are no photon-emitting radionuclides
of suitable half-life for quantitative imaging measurements. None-
theless, the high-energy 32P beta particle will undergo ~2 %
bremsstrahlung energy-loss interactions in water or soft tissue
and, like other radionuclides that emit high-energy beta particles
such as the various radionuclides of yttrium, the resulting radia-
tion can be scintigraphically counted and imaged (Balachandran
et al., 1985; Boye et al., 1984; Feitelberg and Loevinger, 1955;
Kaplan et al., 1981).
Alternatively for beta-emitting radionuclides for which a suit-
able photon-emitting radionuclide does not exist, chemical
homologs of the therapeutic radiopharmaceutical labeled with a
photon-emitting radionuclide may be used. For example, 111In- and
90Y-ibritumomab tiuxetan (an IgG murine monoclonal antibody
1
directed against the CD20 antigen found on the surface of normal
and malignant B lymphocytes) are components of the Zevalin®
(ibritumomab tiuxetan) (Biogen Idec, Cambridge, Massachusetts)
regimen (Conti et al., 2005). Zevalin® is used for treatment of
patients with relapsed or refractory low-grade, follicular, or trans-
formed B-cell non-Hodgkin’s lymphoma, and also for patients with
follicular B-cell non-Hodgkin’s lymphoma that is refractory to
Rituxan® (rituximab) (Biogen Idec, Cambridge, Massachusetts)
therapy. Yttrium-90-ibritumomab tiuxetan is the actual therapeu-
tic component of the regimen but is labeled with the pure beta-
emitter 90Y and is not imageable. Photon-emitting 111In-ibritumo-
mab tiuxetan is, therefore, used as an imaging surrogate to verify,
in advance of the therapeutic administration of 90Y-ibritumomab
tiuxetan, that the expected distribution of the labeled antibody is
obtained.
The use of beta-emitting radionuclides simplifies certain radia-
tion safety issues in radionuclide therapy. For beta energies
<1 MeV used in such therapy, electrons have maximum ranges in
water or soft tissue of only several millimeters and, thus, would
be almost completely absorbed by the patient's tissues, effectively

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3.3 CLINICAL ASPECTS / 45

eliminating any external radiation hazard. However, a small


portion of the beta-particle energy will be lost as bremsstrahlung
resulting in the emission of generally low-energy photon radiation.
As an example, for 32P, the beta particle will undergo ~2 %
bremsstrahlung energy loss yielding a photon energy spectrum
with a broad maximum of ~70 keV (Balanchandran et al., 1985). In
practice, with the relatively low electron energies encountered
in radionuclide therapy, the low abundance and energy of associ-
ated bremsstrahlung makes the external radiation hazard insignif-
icant. Accordingly, there is no need to isolate or otherwise limit
access to patients who have received radiopharmaceutical therapy
with a beta emitter unless contamination is suspected (Zanzonico
et al., 1999). Standard precautions should be adequate for such
patients. A list of liquid radioactive materials commonly used for
therapeutic treatments is given in Table 3.2.
The use of radiopharmaceuticals labeled with alpha emitters is
an emerging modality (McDevitt et al., 1998; 1999; Sgouros, 1999).
The use of these sources labeled to monoclonal antibodies offers the
opportunity to deliver large doses of radiation with little or no
external radiation hazard to staff taking care of these patients.
Accordingly, there is no need to isolate or otherwise limit access to
patients who have received radiopharmaceutical therapy with a
alpha emitter unless contamination is anticipated. A listing of
alpha-emitting radionuclides currently in use or under develop-
ment for use with various compounds is given in Table 3.3.
Besides the foregoing dosimetric considerations, the selection of
a therapeutic radionuclide depends on several circumstances
including its availability, the cost of the radionuclide and the regu-
latory approval of the radiopharmaceutical.

3.3 Clinical Aspects

This Section discusses in generic terms equipment and


procedures necessary to satisfy the clinical requirements for a
radiopharmaceutical therapy program. This listing cannot be com-
prehensive and deals primarily with radiopharmaceuticals for
which FDA has approved a new drug application, although
research materials in investigational new drug application
Phase II and III trials may be included. A listing of radionuclides
and compounds commonly used for radiopharmaceutical therapy is
given in Tables 3.1 and 3.2. This Section is intended to indicate
requirements that may be incorporated into the larger clinical pro-
gram within a medical facility.

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46 / 3. RADIOPHARMACEUTICAL THERAPY

TABLE 3.2—Liquid radioactive materials commonly used for


therapeutic treatment.a

Typical Medical Use


Radionuclide
Activities Usedb (chemical form)

32
P 111 – 185 MBq Polycythemia vera (sodium
phosphate)

Essential thrombocytosis
(sodium phosphate)

Synovectomy (chromic
phosphate)

296 – 444 MBq Bone pain (sodium


phosphate)

370 – 555 MBq Malignant effusions (chromic


phosphate)
131
I 185 – 740 MBq Hyperthyroidism (sodium
iodide)

2.59 – 3.7 GBq Thyroid ablation (sodium


iodide)

1.11 – 14.8 GBq Thyroid cancer (sodium


iodide)

Activity required to Lymphoma therapy (labeled


deliver 65 – 75 Gyc antibody Tositumomab)
89
Sr 148 MBq Bone pain (strontium
chloride)
153
Sm 37 MBq kg –1 of body Bone pain (samarium
weight lexidronam, a chelate)
90
Y 11.1 – 14.8 MBq kg –1 Lymphoma therapy
of body weight up to (yttrium-labeled antibody,
1.19 GBq ibritumomab tiuxetan)
a
The actual activities used for any individual patient will be individually pre-
scribed by the treating nuclear-medicine physician and may vary considerably
from the amounts shown.
b
The activities listed are only an indication of what may be used. This list is
not a substitute for an individual prescription and is not a prescribing manual.
cThe dose shown is an estimated whole-body absorbed dose. The prescribed

activity will require a dose calculation prior to therapeutic administration. This


compound is a monoclonal antibody.

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3.3 CLINICAL ASPECTS / 47

TABLE 3.3—Physical properties of alpha-emitting radionuclides


currently in use or under development with various compounds.

Radionuclide Physical Half-Life Energy (MeV)

225
Ac 10 d 5.9
211
At 7.2 h 5.8
212
Bi a 1.0 h 6.0
213
Bi b 46 min 5.8
224Ra
3.71 d 5.7
aGenerator-produced
isotope; parent radionuclide is 224Ra.
bGenerator-produced
isotope; parent radionuclide is 225Ac.

3.3.1 Instrumentation

A medical facility performing radionuclide therapy should have


instrumentation for measuring activity in vivo for the procedures
performed. Some therapeutic administrations (e.g., 89Sr therapies)
are performed with standard activities which are not customized to
the individual patient, and assessment of the activity distribution
may not be performed after the treatment. Typical instrumenta-
tion may include an uptake probe and one or more gamma cameras,
preferably one of which has the capability of performing single-
photon emission computed tomography imaging. Such instrumen-
tation should be used to verify, at least qualitatively, the distribu-
tion of therapeutic radiopharmaceuticals in individual patients
and, possibly, to quantify tissue activities for radiation dosimetry
and treatment planning. However, with the use of beta-emitting
radionuclides, including 32P, 89Sr, and 90Y, imaging may be limited.
The use of “imageable” surrogate radiopharmaceuticals for thera-
peutic agents labeled with such radionuclides may be necessary as
discussed in the previous section.
Measurement of activity in vivo may be accomplished using a
nonimaging gamma counting system consisting of a sodium-iodide
[Nal (Tl)] detector generally used for 131I thyroid uptake measure-
ments. Modern, commercially available uptake probes are gener-
ally supplied as integrated, computerized systems with automated
data acquisition and processing capabilities that yield results
directly in terms of percent uptake of the administered activity.

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Patient data are normalized by comparing the net count rates (i.e.,
background corrected count rates) between that of a calibrated
standard and the administered activity. As with all clinical instru-
mentation, a documented QA program for uptake probes shall
be implemented. The program should include daily examination
of pulse-height spectra to verify that the radionuclide-specific pho-
topeaks are symmetric and centered within the corresponding
photopeak energy windows. Daily measurement of counting effi-
ciency and stability (net count rate per unit activity) shall be made
using an independently calibrated standard traceable to the
National Institute of Standards and Technology (NIST) to verify
constancy over time, with or without other testing. Measurement of
activity, typically prior to administration, can be accomplished
using a dose calibrator (see Section 3.3.3 for a discussion of this
instrument).
Radionuclides in vivo are most commonly measured using a
gamma camera, also known as an Anger or scintillation camera,
consisting of an energy-appropriate multihole collimator, a large-
area “thin” sodium-iodide [Nal (Tl)] scintillation crystal, an array
of up to 100 photomultiplier tubes, a high-voltage power supply,
preamplifiers, amplifiers, analog or digital position and energy
determination circuitry, energy discriminator, display, patient
table/palette, and an electronic gantry. Modern, commercially
available gamma cameras are supplied as integrated, computer-
ized systems with automated data acquisition, processing, storage
and display capabilities, associated software and online spatial
linearity, energy and sensitivity corrections which may be updated
to maintain optimum system performance. A documented QA pro-
gram for gamma cameras shall be implemented, that includes daily
examination of pulse height spectra, daily qualitative or quantita-
tive evaluation of intrinsic or extrinsic uniformity, and weekly
qualitative evaluation of intrinsic or extrinsic spatial resolution.
A complete discussion of QA programs cannot be presented in
this Report. However, information on such programs is available
from the following organizations directly or from their websites:
American College of Radiology, Society of Nuclear Medicine, the
American Association of Physicists in Medicine, and the American
Society of Nuclear Cardiology.
Instrumentation, typically a scintillation well counter system,
should also be available to measure activity in patient samples,
such as blood or urine. Additional instrumentation such as multi-
channel analyzers or radionuclide thin-layer-chromatography ana-
lyzers may be available as needed for testing of radionuclide purity
or radiopharmaceutical assays.

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3.3.2 Prescription of Administered Activity

There is currently no standardized algorithm for prescribing the


administered activity in radionuclide therapy. Although an in-
depth discussion is beyond the scope of this Report, a brief survey
of such algorithms may be helpful.
Typically, therapeutic radiopharmaceuticals are administered
at standard fixed activities (in gigabecquerel or millicurie), stan-
dard fixed activities per unit body mass (MBq kg –1or mCi kg –1) or
standard fixed activities per unit body surface area (MBq m–2
or mCi m–2) as determined empirically from clinical trials to yield
an acceptable maximal frequency or severity of toxicity and an
acceptable minimal frequency or extent of therapeutic response. In
some cases, the normal tissue toxicity-based approach to prescrib-
ing administered activities has been refined by determining the
total-body or the critical normal-tissue absorbed dose per unit
administered activity (Gy MBq–1 or Gy mCi–1) and administering
the maximal “safe” activity, that is, the maximal activity that
would not deliver a prohibitively toxic normal-tissue absorbed dose.
In radioiodine therapy of metastatic thyroid cancer, Benua et al.
(1962) empirically determined that the maximal “safe” adminis-
tered activity generally corresponded to a mean absorbed dose to
blood of 2 Gy. As with many therapeutic radiopharmaceuticals, the
actual critical, or therapy-limiting, tissue is probably hematopoie-
tic red marrow, but the more practically evaluable blood absorbed
dose is often used as an index, or surrogate, of the red-marrow
absorbed dose. In part because of measurement difficulties (such as
relatively coarse spatial resolution, background activity, attenua-
tion, and scatter in reliably estimating target-tissue activities and
in estimating masses in vivo by current radionuclide counting or
imaging techniques) the target-tissue absorbed dose per unit
administered activity may not be used in prescribing therapeutic
administered activities. A notable exception is 131I therapy of
Graves disease hyperthyroidism, where some practitioners admin-
ister a therapeutic activity projected to deliver an absorbed dose of
70 to 120 Gy to the thyroid. It is possible to do this because doses
are based on prior serial thyroid-uptake measurements of a low
activity 131I tracer and dosimetric calculations. Almost always,
however, it is radiogenic normal-tissue toxicity, and usually mar-
row toxicity, that limits and thus dictates the therapeutic adminis-
tered activity (Edmonds and Smith, 1986).
Although rarely followed in current practice, an individualized
treatment planning paradigm for radiopharmaceutical therapy is
generally as follows (Macey et al., 2001; Sgouros, 2005; Siegel et al.,

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50 / 3. RADIOPHARMACEUTICAL THERAPY

1999; Zanzonico et al., 1995): a low activity “tracer” radiopharma-


ceutical administration; time activity measurements in target
(tumor) and nontarget, normal tissue source regions (e.g., an
activity-containing tissue or organ), if possible; absorbed-dose pro-
jections in target and nontarget regions, if possible; determination
of the maximal “safe” and the minimal “effective” administered
activities; and finally the high activity “therapeutic” radiopharma-
ceutical administration with time activity measurements for
determination of the actual therapeutic absorbed doses. It is recom-
mended that the amounts of radiation in radiopharmaceutical
therapy be expressed in terms of absorbed dose, and not in terms of
administered activity. This recommendation provides a consistent
framework for radionuclide therapy based on a standard, radiobio-
logically significant quantity and incorporates all pertinent
patient-specific parameters that can be evaluated practically. How-
ever, it requires an accurate assessment of the target tissue masses
as well as accurate measurement of time-dependent activities or
activity concentrations. To the extent that these quantities are
inaccurate, the derived absorbed dose will be inaccurate as well.
Despite its utilization in select centers, individualized dose-based
treatment planning for radionuclide therapy largely remains an
unrealized goal in clinical practice.
The responsibility for prescribing the administered activity for
radiopharmaceutical therapy rests with the nuclear-medicine
physician. The preparation and administration of therapeutic
radiopharmaceuticals shall be authorized in writing by the
nuclear-medicine physician in the form of a signed prescription. All
prescriptions for therapeutic radiopharmaceuticals shall contain
information unambiguously identifying the patient, the radiophar-
maceutical, the activity to be administered, and the route of admin-
istration. The prescription may also contain clinical information on
the patient’s diagnosis and the name of the referring physician, if
applicable. The information on the prescription should be protected
under applicable patient privacy regulations.

3.3.3 Assay of Administered Activity

The most common clinical device used to measure the activity in


a dosage to be administered to a patient is the so-called “dose cali-
brator,” a sealed, gas-filled, well-type ionization chamber with
user-selectable settings specific for various radionuclides. The med-
ical facility shall ensure that this instrument can achieve an accu-
racy of ±10 % for all therapeutic radionuclides and for all clinically

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3.3 CLINICAL ASPECTS / 51

relevant physical forms and geometries of the radionuclides used in


the facility (NRC, 2005). For example, a given activity of a thera-
peutic radionuclide in a solution-filled syringe will generally yield
very different readings from the same activity of the same radionu-
clide in a metallically clad seed for interstitial implantation placed
in a vial or test tube. Accordingly, manufacturer-provided or user-
derived “correction factors” (i.e., source, volume, and radionu-
clide-specific calibration factors) may be required. The appropriate
correction factor shall be used when assaying the radionuclide
dose. Moreover, checks of precision (i.e., reproducibility of serial
activity measurements and accuracy checks), or constancy (i.e.,
checks against an independently calibrated standard source) over
the range of photon energies used clinically shall be made prior to
first use and on each day of use or clinical operation. The results
should be recorded, signed/initialed, and archived. Linearity
(i.e., checks of measured versus actual activity over the range of
activities used clinically) shall be verified quarterly and the results
recorded, signed/initialed, and archived. Tests for accuracy shall be
performed at least annually using a NIST traceable sealed source.
All these checks should be reviewed by a qualified medical physi-
cist or medical health physicist.
The conventional dose calibrator is designed for assay of x- and
gamma-ray-emitting radionuclides and is not well suited for assay
of radiopharmaceuticals labeled with alpha- or beta-emitting
radionuclides. Although energetic beta particles in a relatively
high atomic number container may produce sufficient x rays
(bremsstrahlung) for detection and assay, the detected signal is
highly dependent on the source geometry and the thickness and
composition of the container or calibrator. Accordingly, special pro-
cedures may need to be developed for the assay of radiopharmaceu-
ticals labeled with alpha or beta emitters. Guidance from the
manufacturer or a qualified medical physicist or radiopharmacist
should be obtained when establishing the specific protocols for
assay of such radionuclides. Alternatively, although not routinely
available in nuclear-medicine laboratories, beta-emitting radionu-
clides may be assayed by liquid scintillation counting or other beta
counting systems.
There may be difficulties in measuring the activity of alpha-
emitting radionuclides if reliance has to be placed completely on
alpha counting. However, all of the alpha-emitting radionuclides
used therapeutically emit photons of various energies. The calibra-
tion, therefore, usually relies on counting of the emitted photons.
The services of a qualified medical physicist or medical health
physicist should be used to set up such calibration systems.

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52 / 3. RADIOPHARMACEUTICAL THERAPY

Importantly, regardless of the source and the timing of prior


radioassays the activity in each dosage of a radiopharmaceutical
shall be assayed as close as possible to the time of clinical adminis-
tration and the results recorded, signed and archived. The residual
activity, including that in any intravenous tubing used to adminis-
ter the dosage, shall be assayed promptly after administration so
that the actual administered activity can be calculated.

3.3.4 Acceptance Criteria for Therapeutic


Radiopharmaceuticals
The identity and quantity of all radioactive and nonradioactive
components of any radiopharmaceutical preparation shall be
known prior to administration to a patient. The manufacturer or
supplier should provide such a description, typically in the form of
a package insert, of the radiopharmaceutical preparation as well as
information on shelf-life under specified storage conditions. The
ultimate responsibility for the proper administration of radionu-
clide therapy rests with the nuclear-medicine physician, not with
the referring physician or other medical personnel. The attending
nuclear-medicine physician shall ensure that the composition of
the radiopharmaceutical preparation at the time of administration
has been established accurately. Other considerations including
cost, especially in the case of agents in limited supply, should not
compel the attending nuclear-medicine physician to administer a
suboptimal or inadequately characterized radiopharmaceutical
preparation. Information from human and nonhuman toxicology
and efficacy studies generally provided by the manufacturer or
supplier or information from prior clinical experience should be
used in such a way that the nuclear-medicine physician can ensure
that the radiopharmaceutical is acceptably safe and efficacious for
the patient and the condition for which it is being administered.
Co-administered solutions and pharmaceutical preparations shall
be compatible with the radiopharmaceutical and shall not signifi-
cantly reduce its bioavailability by the route administered or alter
its expected biodistribution in vivo.
Therapeutic radiopharmaceutical preparations shall meet the
pharmaceutical criteria set by USP (2004a; 2004b) and FDA.
The activity actually administered (i.e., the difference between the
gross activity assayed immediately prior to administration and
the residual activity assayed immediately after administration)
shall be ±10 % of the activity prescribed by the nuclear-medicine
physician. For in-house radiopharmaceutical preparations, suffi-
cient QC procedures shall be in place to allow for independent

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3.3 CLINICAL ASPECTS / 53

verification by the facility of the pharmaceutical quality and radio-


nuclide purity. In large programs, consultation with a pharmacist
in the development of these techniques may be required. In addi-
tion, parenterally administered radiopharmaceutical preparations
shall be isotonic, at physiologic pH, sterile, and pyrogen-free. As
noted above, regardless of the source and timing of prior radioas-
says, the activity in each dosage of a therapeutic radiopharmaceu-
tical preparation shall be assayed as close as possible to the time of
the actual administration.

3.3.5 Administration of Therapeutic Radiopharmaceuticals

Therapeutic amounts of radiopharmaceuticals shall be stored,


transported and administered with the use of sufficient shielding
so as to maintain personnel exposures ALARA. For orally-adminis-
tered therapeutic radiopharmaceuticals, the activity-containing
vessel should be placed in a shielded, spill-proof container with a
port, or opening, for the patient to ingest the material, typically
drinking a liquid through a straw or taking a capsule. For intrave-
nous use of therapeutic radiopharmaceuticals administered by
bolus injection, the activity-containing syringe should be placed
within a syringe shield with a transparent window that allows
visual monitoring of the injectate. For a beta-emitting radionuclide,
a plastic syringe shield should be sufficient to reduce hand expo-
sure and minimize the production of bremsstrahlung. For intrave-
nous therapeutic radiopharmaceuticals administered by “slow,”
or drip, infusion, the activity-containing container, typically an
intravenous bag, should be placed within a suitable shield. For
high-energy photons, such shields will typically be made of a signif-
icant thickness of lead such that weight considerations with the
stands and measurement devices would need to be evaluated.
Intravenous administrations involving the use of infusion pumps
would also require shielding the pump, if possible, during the infu-
sion. The advice of the RSO or designee in such decisions is
essential.
The procedure for administering a therapeutic radiopharma-
ceutical shall be compatible with its physicochemical properties to
ensure as complete a delivery as possible of the prescribed thera-
peutic activity. For example, certain types of tubing material may
adsorb certain radiopharmaceuticals and thereby result in a
smaller-than-intended administered activity. Inline filters shall be
appropriate for and compatible with the radiopharmaceutical. For
example, administration of radiolabeled antibodies requires a low-
protein-binding filter. It should be noted, however, that filters

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54 / 3. RADIOPHARMACEUTICAL THERAPY

purposefully retain particulates, including antibody aggregates,


and that such retention shall be factored into the amount actually
delivered into the patient. Syringes, burettes, cups, tubing and
other materials used in the administration should be flushed or
rinsed with isotonic saline (or other physiologic buffer) for
parenteral administration. The use of water rinses may be suffi-
cient for oral administration to achieve complete or near-complete
administration of the prescribed activity to the patient. All materi-
als resulting from such administrations shall be considered as
medical and radioactive waste and stored in an appropriate
manner (see Section 2 for a brief discussion of radioactive waste
disposal methods).
Immediately prior to administration of a therapeutic radiophar-
maceutical, the following information, as applicable, should be
verified by two individuals:

• dose on the radiopharmaceutical label matches the prescrip-


tion;
• identification of the patient by two independent means;
• identity of radionuclide;
• identity of radiopharmaceutical;
• total activity;
• date and time of calibration; and
• precautions to be followed.

The administered activity should be verified in a dose calibrator or


other suitable device to ensure that the total activity does not devi-
ate from the prescribed administered activity by >10 %. After
administration of the therapeutic radiopharmaceutical, the resid-
ual activity in the syringe, cups, tubing, inline filter, or other mate-
rials used in the administration should be assayed so that
corrections to administered activity can be calculated.
To avoid administration of a therapeutic radiopharmaceutical to
the wrong patient, the identity of the patient should be verified ver-
bally with the patient and checked by a second independent
method. Patient identification errors can result from simple prob-
lems, such as difficulty in comprehension of the spoken language,
or from more complex problems, such as problems of physical
impairment (visual, auditory or mental states) due to medica-
tion(s). The second verification method shall be sufficiently sophis-
ticated to eliminate problems of patients with the same or similar
names (e.g., the use of social security number, photo identifications,
etc.). As necessary, the services of a translator should be obtained
for patients whose comprehension of spoken English inhibits their

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3.3 CLINICAL ASPECTS / 55

consent or understanding. For inpatients, the identity of the


patient should also be verified by crosschecking the requisition and
the patient's wristband and chart. A therapeutic radiopharmaceu-
tical shall never be administered to a patient whose identity cannot
be definitively verified.

3.3.6 Addressable Events

An addressable event may be considered to be any clinical or


technical event that occurs in the course of planning, executing
or managing a radiopharmaceutical therapy procedure which has
a significant effect on the safety or efficacy of the procedure and
which could have been avoided by appropriate procedural changes.
The following are examples of such events:

• administration to a patient of a radiopharmaceutical or


radionuclide other than that prescribed;
• administration of a radiopharmaceutical with a radionu-
clidic or a radiochemical purity less than the applicable
specification required by USP or FDA at the time of admin-
istration;
• administration of a therapeutic dose of a radiopharmaceuti-
cal which deviates from the prescribed dose by >10 %;
• administration of a radiopharmaceutical to a patient other
than the intended patient; and
• failure to account for effects on radiopharmaceutical dis-
tribution of prior, concurrent or subsequently prescribed
medication(s), solutions, or medical procedures which may
compromise therapeutic efficacy.

Addressable events in radiopharmaceutical therapy shall be


reported to the RSO and treating physician as soon as they are dis-
covered. The RSO in consultation with the treating physician and
the facility administration can then determine if these events meet
regulatory standards for reportability. These events should also be
reported to the patient and the referring physician as soon as pos-
sible, preferably within one working day of the discovery. Dose esti-
mates should be available to evaluate the absorbed doses to specific
organs. The attending nuclear-medicine physician shall decide if
there would be any expected medical consequences of an event. The
dose estimates, timing of further administrations, and clinical
effect(s) of the original administration will affect such a decision.
Appropriate interventions, such as hydration or attempts to block
uptake (e.g., the administration of stable iodides in radioiodinated

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56 / 3. RADIOPHARMACEUTICAL THERAPY

monoclonal antibody therapy) shall be considered in light of the


patient’s overall medical condition, the medical consequences of
the event and the effects of any intervention. Short- and long-term
medical management of such events shall be planned carefully on
an individual basis (NRC, 2004).
Even if an event results in no demonstrable harm to the patient,
it may represent a procedural lapse, a breakdown in existing sys-
tems, or lead to the identification of systematic problems which
need to be addressed. Addressable events may result from human
error. However, such a finding should not preclude consideration
of factors that contribute to these errors, including the workload
of the individual, staffing issues, and the working environment.
Certain addressable events may meet the criteria for reporting to
regulatory agencies. A careful analysis shall be performed to deter-
mine the cause or causes of the event. This analysis should include
interviews of involved personnel, reviews of pertinent policies and
procedures, reviews of training, and consideration of any other rel-
evant factors. A plan for actions to prevent a recurrence should
be developed; these actions should address the causes identified by
the causal analysis (NRC, 2005). If appropriate, remediation,
including further education of personnel or development of further
safeguards, should be implemented.

3.3.7 Considerations in Patient Confinement

In considering the release or confinement of patients during and


after treatment, the nuclear-medicine physician shall determine
that the patient is willing and is physically and mentally able to
comply with appropriate radiation safety precautions in the medi-
cal facility should medical confinement be necessary or at home
after release. Other factors affecting this decision are discussed in
Section 3.4. Importantly, if the nuclear-medicine physician deter-
mines that the patient is unwilling or unable to comply and would,
therefore, pose a radiation hazard to the staff of the medical facility
and others, radiopharmaceutical therapy may be withheld and
alternative treatments considered. If the nuclear-medicine physi-
cian determines that a patient, despite difficulties, may nonethe-
less be safely treated with appropriate and reasonable medical
supervision while hospitalized, patient treatment may proceed.
The nuclear-medicine physician can determine that such patients
can and should remain hospitalized beyond the period of time dic-
tated by any other criteria. As an example, for an incontinent
patient, the nuclear-medicine physician may determine that hospi-
talization of the patient be extended to ensure safe collection and

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3.3 CLINICAL ASPECTS / 57

disposal of radioactively contaminated urine. Both the radiological


and clinical considerations shall be given due weight by the
nuclear-medicine physician. These considerations are discussed
further in Section 3.4 and Appendices A and B.

3.3.8 Special Considerations for Female Patients

Deterministic effects can be produced in the human embryo or


fetus following irradiation. All of these effects are temporally
related to the stage of pregnancy (see Table 4.1 in NCRP, 1994).
Because radionuclide therapy typically involves the administration
of high activities, typically at gigabecquerel levels, such therapy is
generally contraindicated in pregnant women, unless there is no
viable alternative. Signs alerting female patients and containing
wording similar to, “If you are pregnant or if it is possible you may
be pregnant, please notify the staff before the beginning of any
procedure,” should be prominently posted throughout the nuclear-
medicine areas, particularly in waiting and dressing areas. A preg-
nancy test shall be performed before radionuclide therapy in any
female patient of childbearing age. Assertions by the patient or her
family regarding the impossibility of a pregnancy because of medi-
cal condition, sexual inactivity, use of birth control measures, or
recent menstrual history, should not preclude performing a preg-
nancy test prior to radionuclide therapy (Zanzonico and Becker,
1991). Physicians and other readers may wish to consult NCRP
Commentary No. 9 (NCRP, 1994).
The use of 131I therapy for thyroid diseases in pregnant or poten-
tially pregnant women is particularly problematic because radio-
genic destruction of the iodine-avid fetal thyroid may result from
such treatment and could cause hypothyroidism in utero and cre-
tinism. The fetal thyroid begins concentrating iodine at the 12th to
15th week of gestation and fetal absorbed doses can be >10 Gy per
37 MBq administered to the mother, depending on gestational age
and maternal thyroid uptake. Therapeutic administered activities
of 0.37 to 3.7 GBq of iodine would, therefore, result in fetal thyroid
absorbed doses from 100 to 1,000 Gy, respectively. Case reports that
include administered activity, gestational age, and follow-up of
pregnant women treated with radioiodine for hyperthyroidism or
thyroid cancer indicate that the outcome of pregnancy with regard
to fetal thyroid function at birth did not appear to be compromised
in the cases when radioiodine was given before the 10th week
of pregnancy. However, there was essentially a 100 % occurrence of
congenital hypothyroidism or cretinism when radioiodine was
administered thereafter, even in amounts <5 GBq (Zanzonico and

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58 / 3. RADIOPHARMACEUTICAL THERAPY

Becker, 1991). Pregnancy is a contraindication to radioiodine ther-


apy and, as stated above, a pregnancy test shall be performed
before administration of such therapy in any female patient of
childbearing age.
Virtually any systemically administered material, including a
therapeutic radiopharmaceutical, will appear to some extent in the
milk of a lactating female. Radiopharmaceuticals will, therefore, be
transferred to and irradiate a breastfed infant. The generally high
administered activities of therapeutic radiopharmaceuticals may
result in relatively high activity concentrations in milk and inges-
tion, cumulatively, of relatively high activities by the infant. More-
over, because of their small size and the inverse relationship
between absorbed dose and mass, ingestion of even a relatively
small amount of activity by an infant will result in proportionately
large total body and organ absorbed doses. Further, because of
proximity of the infant to the mother when nursing, there is a
potentially significant external absorbed dose to the infant. It is
the responsibility of the administering physician, typically the
nuclear-medicine physician, to ascertain if a patient is nursing a
child by breast prior to administration of a therapeutic radiophar-
maceutical. Accordingly, nursing is generally a contraindication
to radiopharmaceutical therapy and shall be discontinued prior to
radiopharmaceutical therapy. The duration of the cessation of
nursing will depend on the radionuclide and its effective half-life
in vivo, the administered activity, and the extent to which the radi-
onuclide is concentrated in breast milk. For those who choose,
breast milk may be collected with a breast pump and refrigerated
for several days before administration of a therapeutic radiophar-
maceutical. Based on radioassay of serial milk samples expressed
with a breast pump, nursing may be resumed when the breast milk
is no longer detectably radioactive except in the case of 131I as dis-
cussed below. Signs alerting women with language such as, “If you
are breastfeeding, please notify the staff before the beginning of
any procedure,” should be prominently posted in the nuclear-
medicine areas, particularly in waiting and dressing areas. Where
facilities serve non-English speaking populations, signs in the
appropriate languages should also be posted.
Iodine-131 therapy of thyroid disease in nursing mothers pre-
sents particular problems because of the relatively long physical
half-life (8 d) and the significant localization of radioiodine in their
milk and the resulting high thyroid absorbed dose in infants.
Accordingly, nursing by women who have received therapeutic
amounts of 131I shall be discontinued permanently for a baby who
is currently nursing, as it is impractical to expect a mother to

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3.3 CLINICAL ASPECTS / 59

resume nursing after discontinuing nursing for up to several


months.
The majority of radiopharmaceutical therapy, by far, is in the
form of 131I. The sodium-iodide symporter protein, which actively
transports iodide across the cell membrane, is found not only in the
thyroid gland but also in other tissues, particularly lactating mam-
mary glands (Spitzweg and Morris, 2002). The role of sodium-
iodide symporter in the mammary gland is to actively transport
iodide into the milk, thereby supplying iodide to the infant. The
length of time required for down-regulation of sodium-iodide sym-
porter protein production in mammary tissue after cessation of
breastfeeding varies but has been reported in some cases to be in
excess of five weeks (Hsiao et al., 2004). Administration of 131I too
soon after cessation of breastfeeding both increases the radiation
dose to the radiosensitive breast tissue of the woman as well as
complicates the interpretation of the images acquired (Bakheet
et al., 1998). Because of the localization of radioiodine in breast tis-
sue as well as breast milk, assessment of the breastfeeding status
of the woman shall be made prior to scheduling treatment. Accord-
ingly, nursing by women who will receive or have received thera-
peutic amounts of 131I shall be discontinued permanently for a baby
who is currently nursing.
For female patients who may be menstruating during or imme-
diately after a therapeutic administration, there may be detectable
contamination on pads or tampons. Local regulations may differ
regarding disposal of these items. It is recommended that these
items be collected for the first 1 to 3 d post-administration and be
held for decay to background levels prior to proper disposal.

3.3.9 Heritable Effects and Genetic Counseling

Even after comprehensive studies of well over 10,000 children


born to the atomic-bomb survivors in Hiroshima and Nagasaki
with mean gonadal doses of >0.3 Gy, there remains no direct evi-
dence for heritable radiation effects in humans. The estimation of
human genetic risks is, therefore, based largely on data derived
from laboratory studies in animals, introducing the considerable
uncertainty of extrapolation from nonhuman systems to humans.
The total risk per gray per million progeny of the first generation
as a percent of baseline is from 0.41 to 0.64 (NAS/NRC, 2006).
Although the numbers of patients are small, several studies
have generally demonstrated little or no radiogenic germ-cell
mutagenesis among thyroid cancer patients treated with large
amounts of 131I (Edmonds and Smith, 1986; Sarkar et al., 1976).

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60 / 3. RADIOPHARMACEUTICAL THERAPY

The absorbed dose to the gonads for 131I therapy is relatively low
(i.e., <1 Gy) for administered activities of several gigabecquerel
(Zanzonico, 1997). In view of these doses, the high threshold for the
induction of permanent sterility in human beings (i.e., 3.5 Gy for
the testis and 2.5 Gy for the ovary) and the low risk factors
for radiogenic germ-cell damage, it is not surprising that there is a
general absence of impaired fertility and of birth defects among
subsequently conceived children of 131I therapy patients (NAS/
NRC, 2006). Nonetheless, demonstrable but transient gonadal
damage, such as impaired fertility based on sperm counts over the
first year post-treatment, may occur among 131I therapy patients
(Edmonds and Smith, 1986; Handelsman and Turtle, 1983). Fol-
low-up studies of such patients indicate that among male patients
there is a time dependent recovery of sperm count. This may take
as long as 2 y in some cases. Longer-term studies (i.e., 10 y or longer
post-treatment among both male and female patients) indicate that
fertility and the frequencies of miscarriages and congenital abnor-
malities among their offspring are comparable to control values.
Collectively these findings are generally consistent with the results
of the seminal studies of Russell and associates in male and female
mice (Russell, 1977; Russell and Kelly, 1982). The general consen-
sus is that males should forego fathering children for at least six
months after high-dose radioiodine therapy and females should
avoid becoming pregnant for 12 months after such therapy. The
rationale for the waiting period for males, in addition to allowing
for the physical decay of 131I, is that 131I therapy has been found to
be associated with transient impairment of testicular germinal cell
function and any damaged spermatozoon are replaced after four
months (Hyer et al., 2002; Pacini et al., 1994). For females, the
waiting period allows the body to regain normal hormonal balance
that contributes to a more successful pregnancy and allows confir-
mation of complete disease remission with follow-up scans (often
performed with 131I) at 12 months post-therapy (Casara et al., 1993;
Schlumberger et al., 1996). Follow-up scans would, of course, be
problematic if the patient were pregnant. These waiting periods
would also avoid the frustration caused by possible transient
impairment of fertility. Accordingly, following high activity radiop-
harmaceutical therapy, male patients and female patients should
be advised to forego attempting to have children for at least 6 and
12 months post-therapy, respectively. Some patients may wish to
consider the possibility of sperm banking and other techniques
based on their individual situations, and genetic counseling ser-
vices should be available to patients wishing to pursue these
options.

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3.4 RADIATION SAFETY PROCEDURES / 61

3.4 Radiation Safety Procedures

These procedures should be considered supplemental to the


radiation safety program requirements discussed in Section 2.
Operational radiation safety is also discussed in NCRP Report
No. 105, Report No. 127, and Report No. 134 (NCRP 1989; 1998;
2000) and Siegel (2004) as well as documents issued by other pro-
fessional scientific organizations.
Decisions as to whether or not physicians, nurses and other per-
sonnel caring for or working in the vicinity of radioactive patients
are to be classified as radiation workers are to be made by the RSO
in consultation with facility management and the RSC. To mini-
mize exposure of personnel, it is generally recommended that
patients receiving therapeutic amounts of activity not be concen-
trated in one area or treated at one time but dispersed spatially and
temporally (if clinically acceptable). However, there are circum-
stances where such dispersal may not be possible and it may be
necessary to concentrate patients in designated areas under care of
specially trained, experienced personnel. Such decisions are a mat-
ter of facility policy and should involve consultation with the RSO
to ascertain that the ALARA principle is maintained. Pregnant
women shall not be responsible for the routine care of patients
receiving therapeutic amounts of radiopharmaceuticals.
Generally, there is no need to isolate or otherwise limit access to
patients who have received radiopharmaceutical therapy with a
beta emitter. Standard precautions should be used with these
patients. However, there may be special circumstances, as with
marrow ablative therapy, where the potential for contamination is
significant. With such patients the RSO should ensure that the
staff is given special instruction in the procedures to be followed.
Special care should be taken to avoid the possibility of beta emit-
ters coming in contact with the skin of the caregiver, especially if
such emitters have the potential to bind with chemicals in the body.
In the event that residual contamination is determined to be
present, immediate decontamination should proceed until the
residual contamination is reduced to a level acceptable to the RSO.
Unless otherwise specified by the RSO, nurses, physicians and
other health care personnel are to perform all routine duties,
including those requiring direct patient contact, in a normal
manner but personnel should avoid lingering near the patient
unnecessarily. Patients should be apprised in advance of the neces-
sity for medical personnel to minimize close or direct contact so that
this precaution will not be interpreted as a lack of concern. To the
extent possible, verbal communication with the patients should be

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62 / 3. RADIOPHARMACEUTICAL THERAPY

conducted from a distance (e.g., the doorway to a room). Housekeep-


ing, food service, and other ancillary personnel should likewise per-
form all essential routine tasks expeditiously and should avoid
entering the patient's room for nonessential tasks. In an inpatient
setting, ancillary personnel should not enter the patient's room
without conferring with the nursing staff. Personnel caring for such
a patient or otherwise entering the room should observe standard
precautions and thoroughly wash their hands after leaving the
patient's room. In selected cases, persons entering the room of a
patient may be asked to don protective clothing before entering and
to leave such clothing in the area after exiting the room. These pre-
cautions are to be decided on an individual basis by the facility RSO.
Patients who require hospitalization may have visitors during
the period that radiation precautions are in effect. In addition, a
member of a patient’s family may be permitted to receive up to
50 mSv y–1 on the recommendation of the treating physician. When
family members are likely to receive dose >5 mSv annually, they
should be provided training and individual monitoring as if
they were to be occupationally exposed (NCRP, 1995b). When in the
opinion of the treating physician, there are significant extenuating
reasons to allow members of the family to exceed the dose limita-
tions of Table 2.1, consultation shall be sought with the RSO to see
if the use of portable shielding or limitations on visiting times can
mitigate any potential dose. Special attention shall be given to lim-
itations on the doses to pregnant women and children. Every rea-
sonable effort shall be made to reduce the doses received by
pregnant women and children. The design of specific rooms for
housing patients receiving radiopharmaceutical therapy is dis-
cussed in Section 5.
A patient receiving a therapeutic administration of a radiophar-
maceutical and requiring medical confinement according to the
foregoing criteria shall be placed in a private hospital room with a
private toilet and sink. The nuclear-medicine physician should
arrange with the admitting office for this type of room to be avail-
able immediately prior to administration and for the duration of
the admission. The nuclear-medicine physician should convey the
date of the treatment, the radionuclide, the radiopharmaceutical,
and the prescribed administered activity to the RSO as far in
advance as possible. The nuclear-medicine physician and the RSO
should decide in advance whether or not the patient is suitable for
release on the same day that the radiopharmaceutical therapy is
administered (Sparks et al., 1998). Any limitations for same-day
release will depend on facility and medical decisions but can
include consideration of:

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3.4 RADIATION SAFETY PROCEDURES / 63

• type of dwelling;
• presence in the household of pregnant or breastfeeding
women;
• sex and age of each household member;
• sleeping partner information;
• information on children in the household;
• workplace information and schedule;
• presence in the workplace of pregnant women or minors;
• means of transportation from hospital to home;
• physical challenges;
• incontinence or ostomy care; and
• ability to comprehend instructions.

The discussion in the remainder of this Section assumes that


the patient requires confinement in a medical facility. For a discus-
sion regarding same-day treatment and release without confine-
ment, see Appendices A and B.
On the day of the planned treatment, the patient's hospital
room should be prepared to minimize potential radioactive contam-
ination. The use of disposable plastic-backed absorbent pads taped
in place in the areas most likely to be contaminated, such as
the floor around the toilet and sink, is one option used in many
facilities. The therapeutic radiopharmaceutical, activity, the date
and time of administration, and verification of the assay shall
be entered in some form in the patient's medical record. Prior
to administration of the therapeutic radiopharmaceutical to the
patient, all radiation safety precautions shall be explained to
the patient. If the administration requires admission to the facility,
the patient should clearly understand the necessity to stay in the
assigned room and the limitations on visiting time to avoid any
anxiety. This explanation should take place prior to admission to
the facility so that any questions from the patient can be addressed
in a timely manner and the patient’s anxiety, if any, relieved. A
signed and dated copy of the radiation safety precautions should be
placed in the patient's medical record. Any contaminated items
from the procedure should be labeled with the radionuclide, a radi-
ation precaution sticker, and held for complete decay in storage in
an appropriately shielded and secure area. In practical terms, this
will mean holding material until there is no measurable activity.
Federal or local regulations should also be consulted for specific
requirements.
Anterior exposure rates at the surface of and 1 m from the
patient should be measured at the level of the patient's umbilicus,
using a calibrated radiation monitor, such as a portable ionization

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64 / 3. RADIOPHARMACEUTICAL THERAPY

chamber. These initial measurements should be performed within


1 h of administration of the radiopharmaceutical therapy and prior
to any post-therapy excretion by the patient. The radionuclide, the
radiopharmaceutical, and the activity administered shall also be
recorded in the patient's medical record. A “radiation precautions”
sign should be posted on the door to the patient's room and a “radio-
active precautions” wristband placed on the patient's wrist.
There should be available in the patient’s room a plastic or plas-
tic-lined container for short-term disposal/storage of all disposable
items used by the patient. Food and beverages for the patient
should be provided using disposable trays, cups, utensils, etc. The
patient may use the toilet and dispose of urine and feces as usual,
flushing the toilet several times after each use. The patient’s linens
and gowns may also be contaminated and should be held for checks
by the radiation safety staff before being placed in the facility laun-
dry. In practical terms this will mean holding linen until there is no
measurable activity. Federal or local regulations should be con-
sulted for specific requirements.
Each day following administration of the therapeutic radiophar-
maceutical, the patient should be resurveyed. The point at which
these surveys are made should be the area of maximal uptake of
the radiopharmaceutical. Scans of the patient’s body with a survey
meter may be necessary to find the area of maximal uptake. For
example, in the case of thyroid treatments in patients with intact
thyroids, this area may correspond to the patient’s neck or chest.
The exposure rate measured can then be used to determine release
instructions for the patient, if any. Removal of contaminated items
from the patient’s room should be done on a daily basis.
Upon discharge of the patient, the RSO should arrange for
removal of all remaining waste and contaminated items from the
patient's hospital room. All items should be placed in plastic bags,
using separate bags for disposable and for nondisposable items
(e.g., linens and bedding). All radioactively contaminated
items should be labeled with radiation precaution stickers and
with the radionuclide, date and time, and held for decay-in-storage
in an appropriate shielded and secure area until there is no mea-
surable activity. All waste and other items being held for decay in
storage should be reassayed periodically using a calibrated radia-
tion monitor. Waste should then be discarded appropriately and
bedding and linens may be treated as usual.
The patient's room shall be surveyed and checked for removable
contamination. Initially, this check should be performed using a
handheld survey meter, such as a GM counter or scintillation sur-
vey meter. These checks should be followed as necessary with wipe

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3.5 PATIENT-RELEASE CRITERIA / 65

testing. When the applicable criteria for removable radioactive con-


tamination specified by the RSO are satisfied, the medical facility
should be informed that the room is available for general patient
use.
A list of names and 24 h telephone numbers of individuals to
contact in the event of a radiation emergency shall be available.
This list is separate in function from listings of persons responding
to radiation emergencies in emergency rooms or trauma centers.
Personnel to be contacted may include the RSO and responsible
nuclear-medicine physician or the nuclear-medicine resident or fel-
low on-call. These lists shall be available to medical personnel car-
ing for the patient. Specific instructions for emergency situations
are given in Section 6.
In the event of a large volume spill of blood, urine or vomitus,
nursing personnel should cover the spill with a plastic-backed
absorbent pad and immediately call the designated radiation
safety staff. For inpatients that received regional radiopharmaceu-
tical therapy, spills from these patients will usually contain mini-
mal activity. Medical personnel should not attempt to clean up a
major spill without radiation safety instruction.

3.5 Patient-Release Criteria

The release criteria for patients receiving therapeutic amounts


of radiopharmaceuticals are based on the prevailing recommenda-
tions promulgated in NCRP Report No. 116 (NCRP, 1993b) and
NCRP Commentary 11 (NCRP, 1995b). This Section is supplemen-
tary to the discussion in Section 3.3.5 and incorporates recommen-
dations previously presented in NCRP Report No. 37 (NCRP, 1970).
A discussion of the operational equations governing patient release
and examples of their applications can be found in Appendices A
and B (Zanzonico, 1997; 2000). Regulatory agencies have published
criteria for patient release and these criteria shall be reviewed by
the RSO and the nuclear-medicine physician(s) in facilities admin-
istering therapeutic amounts of radiopharmaceuticals to deter-
mine which criteria apply to the facility-specific program (NRC,
1987; 1997; 2002; 2005).

3.5.1 Doses to Individuals and Family Members

NCRP Report No. 37 and Commentary No. 11 (NCRP, 1970;


1993b) recommended an annual dose limit of 5 mSv annually for
family members caring for or living with persons treated with ther-
apeutic amounts of radiopharmaceuticals. This recommendation

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66 / 3. RADIOPHARMACEUTICAL THERAPY

was based on the consideration that caring for such individuals


most likely represented an once-in-a-lifetime circumstance for the
family member(s). The recommendations required that instruction
be provided to the family member(s) regarding any limitations on
living circumstances, such as sleeping arrangements or care for
small children. These considerations are discussed in Appendices A
and B. There have been a number of reports on the contamination
potential for both the premises occupied by the patients and indi-
viduals caring for these patients (Barrington et al., 1996; 1999;
Buchanan and Brindle, 1970; 1971; Grigsby et al., 2000; Harbert
and Wells, 1974; Jacobson et al., 1978; Macle et al., 1999; Mathieu
et al., 1999; Miller, 1992; Rutar et al., 2001a; 2001b; Ryan et al.,
2000; Siegel, 1998; Siegel and Rutar, 2002; Zanzonico et al., 1999).
Virtually all of these authors have reached the conclusion that the
release of patients treated with therapeutic amounts of radiophar-
maceuticals is not likely to expose any member of the public, inclu-
sive of both external and internal dose contributions, >5 mSv
provided that adequate instructions are provided at discharge to
the patient and the family members.

3.5.2 Travel by Radiopharmaceutical Therapy Patients


An important practical issue with radiopharmaceutical therapy
patients is limitation of travel, because this will typically involve
exposure from the patient to one or more individuals at relatively
close distances in a confined space, such as an automobile or air-
plane. Various authors have reported measurable dose rates at 0.1
to 1 m from 131I treated hyperthyroid and thyroid cancer patients
immediately post-administration (Barrington et al., 1996; Culver
and Dworkin, 1991; Gunasekera et al., 1996; Pochin and Kermode,
1975). While it is difficult to succinctly summarize these data, trav-
eling with a patient for 1 h following administration of 131I is
unlikely to result in an effective dose >1 mSv at a distance 0.3 m or
further from a patient who received an activity of the order of
370 MBq or at a distance 1 m or further from a patient who
received an activity of the order of 3.7 GBq. However, in the case of
administered activities at the latter level and at distances from the
patient of 0.3 m or less, an effective dose >5 mSv may be accrued
>1 h. Thus, travel for 1 h immediately post-treatment in a private
automobile large enough for a patient to maintain a distance of 1 m
or greater from the other occupant(s) is generally permissible.
However, a case-by-case analysis will be necessary to determine the
actual travel restrictions for each patient, especially for longer
trips and for travel by public bus or train, commercial airliner, or
other conveyance in which travelers may be crowded together.

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3.6 EMERGING APPLICATIONS / 67

Patients containing small amounts of radiopharmaceuticals can


cause an alarm from sensitive radiation detectors used at airports,
train stations, and other locations. Patients should be aware of this
possibility and should have a letter or card, containing the appro-
priate information, issued by the treating institution for display to
authorities. Such a card or letter should include a method of veri-
fying this information with the treating facility.

3.6 Emerging Applications

Algorithms for patient-specific dosimetry suitable for radiop-


harmaceutical therapy treatment planning are not yet widely
available (Zanzonico, 2000). As a result, “dose prescription” algo-
rithms in radiopharmaceutical therapy remain relatively simple:

• administration of the same activity to all patients;


• administration of activity per unit body mass or surface
area (MBq kg –1 or MBq m–2) to all patients; or
• administration of the patient-specific activity corresponding
to some empirically determined maximal tolerated dose
(e.g., 2 Gy to the blood, as a bone marrow surrogate, in 131I-
sodium-iodide treatment of metastatic thyroid cancer (Zan-
zonico, 2000; Zanzonico et al., 1995).

The tumor dose is generally not determined and thus is not used
for treatment planning. However, with the application of quantita-
tive positron-emission tomography (PET) imaging, as illustrated
by the use of 124I-iodide in thyroid cancer (Pentlow et al., 1991;
1996; Sgouros et al., 2004), the procedures may be changing. PET
and, in particular, combined PET/computed tomography (CT) is
among the most rapidly expanding areas in nuclear medicine
(Schoder et al., 2003). At present, PET systems employing detector
elements numbering in the thousands, septa-less three-dimen-
sional data acquisition and iterative image reconstruction are
yielding quantitative whole-body images with a spatial resolution
of ~5 mm or better in <30 min (Zanzonico, 2004). Manufacturers
are now also marketing multi-modality scanners, combining
high-performance state-of-the-art PET and CT scanners in a single
device. These devices provide near-perfect registration of images of
in vivo function (PET) and anatomy (CT) and are already having a
major impact on clinical practice, particularly in oncology (Schoder
et al., 2003).

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68 / 3. RADIOPHARMACEUTICAL THERAPY

Another burgeoning area in nuclear medicine is the application


of intraoperative probes, particularly in the detection and localiza-
tion of so-called “sentinel” lymph nodes in breast cancer and in mel-
anoma (Cody, 2002; Zanzonico and Heller, 2000).
Radiopharmaceutical therapies, most notably radioimmuno-
therapy, peptide therapy, and palliation of malignant bone pain,
continue to be areas of intensive investigation. Recently, FDA
approved two radiolabeled anti-CD20 antibodies, Bexxar® (labeled
with 131I; Corixa, Seattle, Washington) and Zevalin® (labeled with
90
Y), for treatment of non-Hodgkin’s B-cell lymphomas (Gates
et al., 1998; Meredith, 2006; Witzig, 2006). Both agents have
proven effective for relapsed and refractory low-grade and trans-
formed lymphomas and have renewed interest in radioimmuno-
therapy of solid tumors (Jhanwar and Divgi, 2005; Pandit-Taskar
et al., 2003; 2004). The development of immune constructs [from
polyclonal antibodies to murine monoclonal antibodies to chimeric
antibodies (composed of a human constant region fused with a
murine variable region) to humanized antibodies (composed of an
antigen-binding region or complementarity-determining region on
a human immunoglobulin structure)] not only improves tumor tar-
geting but reduces the antibody’s immunogenicity and, therefore,
the development of human anti-mouse antibodies. In addition,
improvement of penetration into solid tumor parenchyma and
clearance from normal tissues is being pursued by the use of
smaller immune constructs than intact immunoglobulins. These
include Fab’ and F(ab)’2 fragments and, more recently, single-chain
antigen binding proteins (sFv) (linear constructs of light and heavy
Fv fragments rapidly cleared from blood and having lower renal
retention compared to Fab’ fragments), two sFv fragments linked
by a component of the heavy-chain regions, and dia-bodies (two
covalently linked sFv fragments). To further enhance the efficacy
of radioimmunotherapy, multi-step (or pre-) targeting strategies
are being actively investigated. These are designed to minimize the
radiation dose to normal tissue due to prolonged residence time in
the body while not significantly reducing tumor targeting. One
widely investigated approach utilizes the ultra-high-affinity inter-
action between avidin (or streptavidin) and biotin. The nonradioac-
tive targeting antibody or fragment is conjugated with avidin or
streptavidin before injection. Approximately 1 d thereafter, a clear-
ing agent is administered to reduce the amount of the nonradioac-
tive antibody-(streptavidin) avidin complex remaining in the
circulation and normal tissues prior to administration of the radio-
labeled biotin. Finally, the radiolabeled biotin is injected and
rapidly either binds the radionuclide to the (streptavidin) avidin in

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3.6 EMERGING APPLICATIONS / 69

the tumor or is excreted. Originally, antibodies and antibody frag-


ments were radiolabeled exclusively with radioiodines such as 123I
or, more commonly, 131I. More recently, various chelates are being
used to bind a variety of radiometals such as 90Y and 177Lu to these
agents (Bander et al., 2003).
Peptide-based radiopharmaceuticals were introduced clinically
more than a decade ago, with the somatostatin analog, octreotide,
used for both receptor scintigraphy (with 111In label) and also recep-
tor-mediated peptide radiotherapy with either 111In or 90Y as the
radiolabel of neuroendocrine tumors, remaining the most success-
ful and widely used of these agents (Gotthardt et al., 2004). Such a
peptide must generally be modified with a radiometal chelator com-
plex to allow stable labeling with a so-called residualizing label,
meaning that the radiometal-chelator-peptide complex is internal-
ized via a specific receptor and trapped in target cells. In addition
to octreotide, peptides under development for use as radiopharma-
ceuticals include minigastrin, substance P, and neurotensin.
Potentially debilitating bone pain resulting from skeletal
metastases is a common feature of many advanced cancers, such as
prostate and breast cancer. While ERT remains the principal
approach for pain palliation for solitary skeletal lesions, bone-seek-
ing radiopharmaceuticals are widely used for treatment of multiple
painful osseous lesions (Pandit-Taskar et al., 2004). Although 32P
was used for many years, its associated myelosuppression has
led to the ongoing development of other bone-seeking radiophar-
maceuticals, including 89Sr-labeled strontium chloride (89SrCl),
153Sm-labeled ethylenediaminetetramethylene phosphonic acid

(153Sm-EDTMP), 117mSn-labeled stannous chloride (117mSnCl), and


166
Ho-labeled 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrameth-
ylenephosphonate (166Ho-DOTMP). Currently, 89SrCl and 153Sm-
EDTMP have been approved by FDA for the treatment of painful
osseous metastases.
The use of 90Y labeled microspheres for the treatment of liver
cancers has been approved by FDA. Patients with metastatic
liver tumors, primarily from colorectal cancers, represent the larg-
est group of patients treated using 90Y-microsphere techniques.
However, some centers have elected to use this technique for treat-
ment of primary liver cancers (Herba et al., 1988; Lim et al., 2005;
Stubbs et al., 2001; Welsh, 2006). Yttrium-90 microspheres
have been used with and without concomitant chemotherapy.
Although technically a form of brachytherapy, the necessity for a
hepatic arteriogram and arterial embolization, have resulted
in most of these procedures being performed in an interventional
radiology setting; an area in most facilities where therapeutic

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70 / 3. RADIOPHARMACEUTICAL THERAPY

treatment with radionuclides has not been previously used. Typical


administered activities have varied from 1 to 3 GBq. Physicians
administering the doses may be nuclear-medicine physicians rather
than radiation oncologists. Refer to Section 4.9 for a discussion of
the brachytherapy techniques that may apply. Personnel adminis-
tering these activities should be instructed in the use of plastic
shields and plastic syringe shields, some of which may be supplied
by the pharmaceutical manufacturer (Murthy et al., 2005a; Salem,
2006). Various techniques, including bremsstrahlung imaging,
have been developed to analyze the distribution of the microspheres
following placement (Campbell et al., 2000). The success of this
technique reported to date will possibly lead to the expansion of
this use to other tumors.

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4. Brachytherapy

4.1 Techniques and Basic Terminology

Brachytherapy is a technique that places sealed radioactive


sources adjacent to or in contact with a target tissue. Because the
absorbed dose falls off rapidly with increasing distance from
the sources, high doses (3 to 70 Gy) may be safely delivered to a
well-localized target or region over a short time period; typically
from a few minutes up to one week for temporary implants and a
period from several days to several months for permanent
implants. The procedure of surgically inserting sealed radioactive
sources or placement of catheters or applicators designed to hold
them is known as “implantation.” The term “implant” usually
refers to a completed assembly of sources with or without applica-
tors used for therapeutic intent. Some techniques for regional ther-
apy are discussed in Section 3.
Implantation techniques may be classified by a variety of meth-
ods. In terms of the surgical approach to the target volume,
implants may be termed as interstitial, intracavitary, transluminal
or techniques employing molds. If one designates the means of con-
trolling the dose delivered, implants may be temporary or perma-
nent. Classification in terms of source-loading technology results
in terms such as preloaded, manually afterloaded, or remotely
afterloaded. Finally, techniques can be defined by the dose rate
employed: low, medium or high.
Intracavitary insertion consists of positioning applicators, bear-
ing appropriate sources, into a body cavity in proximity to the
target tissue. Intracavitary treatment is almost universally used in
definitive radiation therapy of locally advanced cervical cancer. All
intracavitary implants are temporary implants that are removed
from the patient as soon as the prescribed dose has been delivered.
The vaginal cylinder is the most commonly used intracavitary
surface-dose applicator in gynecologic brachytherapy.
Interstitial brachytherapy consists of surgically implanting
small sealed radioactive sources, also called “seeds,” directly into
target tissues. Temporary interstitial implants consist of sealed
radioactive sources placed into steel needles or plastic catheters
that are inserted in the target tissue and that are removed at the
end of a precalculated treatment or “dwell” time. A permanent

71

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72 / 4. BRACHYTHERAPY

interstitial implant remains in place for the lifetime of the individ-


ual or until coincidentally removed during surgery. The initial
source strength is chosen so that the prescribed dose is fully deliv-
ered only when the implanted radioactive material has decayed
to a negligible level. Surface-dose application (sometimes called
plesiocurie or mold therapy) consists of an applicator, which may be
customized to individual patient contours, containing an array of
sealed radioactive sources designed to deliver a uniform dose dis-
tribution to skin or a mucosal surface. Transluminal brachyther-
apy consists of inserting a single line source into a body lumen to
treat its surface and adjacent tissues.
Temporary implant technology can be classified in terms of the
method used to introduce, or load, the sealed radioactive sources
into the implant site. The preloaded or “hot source” technique con-
sists of placing the sealed radioactive sources directly, or placing
applicators previously loaded with sources, in the implant site dur-
ing an operative procedure. Since 1970, most temporary implants
are implemented by using manually afterloaded applicator sys-
tems. Nonradioactive or unloaded applicators are inserted into the
patient during an operative procedure. The sealed radioactive
sources are subsequently “afterloaded” into the applicator system
when the patient has returned to his or her room. These tech-
niques, introduced into practice during the early 1960s, eliminate
exposure to operating room personnel and to the hands and fingers
of the radiation oncologist (Henscke et al., 1963; Suit et al., 1963).
For intracavitary therapy, tube-like sources of 137Cs (sometimes
called “intracavitary tubes”) are manually manipulated into plastic
sleeves or inserts that are then introduced into vaginal and uterine
applicators as indicated. For temporary interstitial implants, flexi-
ble plastic tubes or hollow metal needles are inserted into the tar-
get tissue during an operative procedure. After the patient has
returned to his or her room, ribbons containing sealed radioactive
sources are inserted into the hollow applicators. These techniques
are discussed in Section 4.2.2 (see Figure 4.1 for source types).
Radiation exposure to hospital staff responsible for source load-
ing and the care of implant patients during treatment can be
greatly reduced or eliminated by use of remote afterloading tech-
nology (Glasgow, 1995b). A remote afterloading system consists of
a pneumatically or motor-driven source transport system for robot-
ically transferring radioactive material between a shielded safe
and each treatment site. The applicators or catheters are connected
to a shielded safe by means of transfer tubes. Most remote after-
loaders are equipped with a timer that automatically retracts the
sources when the programmed treatment time, corrected for gaps

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4.1 TECHNIQUES AND BASIC TERMINOLOGY / 73

Fig. 4.1. The types of brachytherapy sources shown reflect current


usage in the United States. AL is the active length, EL is the equivalent
active length, and S is the separation between small sources (ICRU,
1997).

and interruptions, has been administered. Use of these devices is


reviewed in more detail later in this Section.
The rate at which absorbed dose is delivered to the treatment
site (prescription dose rate) greatly influences the logistics of treat-
ment delivery, the radiation safety procedures necessary, and the
patient’s response to treatment. According to the conventions of
ICRU Report 38 (ICRU, 1985), dose rates of 0.4 to 2 Gy h–1 at the
prescription point are referred to as low dose-rate (LDR) implants.
To deliver clinically useful total doses of 10 to 70 Gy, treatment
times of 24 to 144 h are required. This requirement limits the prac-
tice of LDR brachytherapy to the inpatient environment. The total
source strength loaded in LDR implants results in low exposure
rates around the patient. Even with manual afterloading tech-
niques, good quality nursing and medical care can be administered
without exceeding acceptable limits for exposure of personnel. The
vast bulk of accumulated clinical brachytherapy experience con-
sists of retrospective studies of patients treated using LDR tech-
niques. Using the ICRU conventions, an HDR implant is one
utilizing prescription dose rates >0.2 Gy min–1 (>12 Gy h–1) (ICRU,
1985). Modern HDR remote afterloaders contain sources capable of
delivering dose rates as high as 0.12 Gy s–1 at 1 cm distance in
tissue. Treatment times are typically of the order of minutes. As

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74 / 4. BRACHYTHERAPY

discussed later in this Section, HDR brachytherapy differs signifi-


cantly from LDR brachytherapy with respect to dose response,
level of technical and logistical complexity required, patient safety
issues, and socio-economic considerations. A heavily shielded treat-
ment room and a remote afterloading device are essential compo-
nents of an HDR brachytherapy facility. HDR brachytherapy is
generally an outpatient treatment modality delivered in discrete
fractions at daily or weekly intervals. From two to eight fractions
of HDR treatment are required to approximate the tumoricidal
effect of LDR implant therapy. An ultra-LDR range (0.01 to
0.3 Gy h–1) is of clinical importance and includes the dose-rate
domain utilized by permanent implants using low-energy seeds.

4.2 Sources, Delivery Technology, and Dosimetry

Classically, “sealed” brachytherapy sources consist of a core that


is coated or impregnated with a radioactive material. This core is
then sealed in a metal sheath or capsule, typically titanium
for low-energy photon sources and stainless steel or platinum for
higher-energy photon sources. Encapsulation prevents leakage of
radioactive material and absorbs nonpenetrating radiation (i.e.,
alpha and beta radiations and very-low-energy photons) that would
otherwise give rise to high surface doses without contributing ther-
apeutic dose at the target distance. Generally, only photons
(gamma rays or characteristic x rays) with energies >15 keV con-
tribute therapeutically significant dose over the 3 to 50 mm range
of distances relevant to brachytherapy. However, this classical def-
inition of a brachytherapy source (i.e., radioactive material perma-
nently sealed in a metal container), is rapidly becoming too narrow.
Balloon applicators inflated with radioactive solutions have been
proposed as a method for treating both malignant and benign pro-
liferative processes (Dempsey et al., 1998). Arterial stents, coated
with beta-emitting radionuclides, have been developed for prophy-
lactic treatment of cardiac arteries to prevent restenosis following
percutaneous angioplasty (Amols et al., 1996b). A more general
and modern definition of a brachytherapy source would include any
device or applicator that physically confines activity within its
boundaries, delivers a therapeutic dose to nearby tissue, and
requires accurate positioning in the patient to deliver the pre-
scribed dose to the intended target tissue.
The important physical properties of radionuclides commonly
used in brachytherapy are listed in Table 4.1. Table 4.2 lists the
radionuclides most commonly used for sealed source brachyther-
apy procedures classified according to the terminology described

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TABLE 4.1—Physical properties of brachytherapy radionuclides.
Half-Value Exposure-Rate
Photon Energy
Radionuclide Half-Life Layer Constanta Γδ Physical Form
(MeV)
(mm Pb) (R cm2 mCi–1 h–1)
226
Rab 1,600 y 0.83 (mean) 12 8.25c Tubes, needles
222 b c
Rn 3.83 d 0.83 (mean) 12 8.25 Seeds
60
Co 5.25 y 1.25 (mean) 12 13 Plaques, needles
137
Cs 30 y 0.662 6.5 3.2 Tubes, needles
192
Ir 74.02 d 0.397 (mean) 3 4.59 Seeds in ribbons, wires, source
on cable
125I
60.14 d 0.028 0.025 1.45 Seeds
103Pd
17 d 0.020 0.008 0.86 Seeds
198Au
2.7 d 0.412 3.3 2.35 Seeds
90Sr/90Y
28.2 y 2.24 (β max) NAd NAd Plaques
241Am
432 y 0.60 0.12 3.14 Tubes
169Yb
32 d 0.093 (mean) 0.48 3.27 Seeds
131Cs
9.69 d 0.030 0.030 1.24 Seeds
145Sm
340 d 0.043 0.060 0.885 Seeds
a
This subscript notation, δ, in Γδ is used to denote that the calculated value does not include the contributions of radiations removed (i.e.,
attenuated due to the presence of encapsulating material).
4.2 SOURCES, DELIVERY TECHNOLOGY, AND DOSIMETRY

bListed for historical significance only.


c
0.5 mm platinum-iridium filtration.
d
NA = Not applicable.
/ 75

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76 / 4. BRACHYTHERAPY

TABLE 4.2—Radionuclides used for implantation.

Technique Traditional Current Future

Intracavitary and Intraluminal Applications


226 137 241
Low dose rate Ra Cs Am, 192Ir, 169Yb
60 60
High dose rate Co Co, 192Ir 192
Ir, 169Yb

Interstitial Implants
226 137
Preloaded Ra Cs —
192Ir 125I, 103Pd, 169Yb
Afterloaded —

High dose rate — 192Ir 192Ir, 169Y

Permanent Implants
222Rn 198Au 198Au, 131Cs
Conventional
dose rate

Ultra-low dose — 125I, 103Pd 125I, 103Pd

rate

previously. Properties such as half-life, photon energy, radiation


output per unit activity, specific activity (Bq g–1, Ci g–1), fabrication
cost, and toxicity all play a critical role in determining the clinical
applications appropriate for each radionuclide. Because the three-
dimensional dose-distribution characteristic of a given source is so
important to appropriate clinical use, a short review of brachyther-
apy dosimetry principles is provided below.

4.2.1 Specification of Source Strength for Photon Emitters

The method of specifying strength of sealed radioactive sources


strongly influences dose-calculation methodology and the level of
dosimetric accuracy achievable. Historically, source strength has
been specified by many different quantities and units including
contained activity, apparent activity, equivalent mass of radium,
mass of radium, and reference exposure rate. Unsealed radionu-
clides have historically been quantified in terms of true or con-
tained activity. Despite frequent use of activity-based units, such as
millicurie, curie and becquerel, sealed sources are almost never
specified in terms of contained activity for the purposes of dose cal-
culation or treatment prescription.

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4.2 SOURCES, DELIVERY TECHNOLOGY, AND DOSIMETRY / 77

For purposes of radiation dosimetry, the term “kerma” relates to


the kinetic energy liberated by uncharged particles; the energy
expended to overcome binding energies, usually a relatively small
component, is not included. Kerma (K) is the quotient of dEtr by dm,
where, dEtr is the sum of the initial kinetic energies of all the
changed particles in a mass dm of material, thus:
dE tr
K = ------------- . (4.1)
dm
The unit of kerma is J kg –1 and the special name for the unit of
·
kerma is the gray. The kerma rate ( K ) is the quotient of dK by dt
where dK is the increment of kerma in the time interval (dt). The
unit of kerma rate is J kg –1 s–1 and the special name is gray per sec-
ond (Gy s–1) (ICRU, 1998a).
Sealed brachytherapy sources are calibrated and specified in
terms of the radiation output (Gy h–1) along the transverse bisector
(i.e., the axis perpendicular to and bisecting the long axis of the
source). Specifically, source strength is specified in terms of air-
kerma rate at a distance of 1 m from the source center. The mea-
sured result shall be corrected for scattering from surrounding sur-
faces (e.g., walls, floors, etc.) as if a vacuum surrounded the source
and detector. The resultant quantity, air-kerma strength, is defined
as the product of the air-kerma rate in free space and the square of
the distance and is denoted by the symbol SK (Nath et al., 1995).
The units of air-kerma strength are μGy m2 h–1 or cGy cm2 h–1,
denoted in this Report by the symbol “U.”3 Units of cGy m2 h–1 are
often used in conjunction with high-intensity HDR sources.

2 –1 2 –1 –4 2 –1
1 U = 1 μGy m h = 1 cGy cm h = 10 cGy m h . (4.2)

A number of older quantities remain in use (Williamson, 1991a).


Cesium-137 tubes, 192Ir seeds, and other radium substitutes are
frequently specified in terms of the equivalent mass of radium with
units of mgRaEq. The strength of a given source in mgRaEq is the
mass (in milligrams) of 226Ra, encapsulated in 0.5 mm of platinum-
iridium that gives the same transverse-axis radiation output, or
air-kerma strength, as the source. One mgRaEq source of 137Cs
or 192Ir has an air-kerma strength (SK) of 7.23 cGy cm2 h–1. Equiva-
lent mass of radium simply describes the radiation output of a

3This should not be confused with the quantity “U” (use factor) com-
monly used in shielding calculations (see Glossary and Symbols and
Acronyms).

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78 / 4. BRACHYTHERAPY

source as a multiple of that of a 1 mg 226Ra needle. Apparent activ-


ity, usually expressed in units of millicurie, is the air-kerma
strength of a source relative to the output of a hypothetical 1 mCi
point source consisting of the same radionuclide as the given
source. Historically, apparent activity was used to quantify
strength of permanently implanted sources such as 125I and 198Au.
However, with newer developments in brachytherapy (e.g., 125I liq-
uid filled reservoir for treating cystic brain tumors) radioactive
sources are frequently prescribed and assayed in activity units.
Use of air-kerma strength (or its numerically identical Euro-
pean counterpart, reference air-kerma rate) in clinical practice has
been endorsed by various standards groups (Williamson et al.,
1993). The radiation-oncology community is gradually replacing
older units and quantities with air-kerma strength in areas of clin-
ical practice. The quantity air-kerma strength should be used for
specifying source strength in treatment planning and treatment
prescription. NIST maintains primary SK standards for the most
commonly used LDR brachytherapy sources (Hanson, 1995).
Transfer of these standards to individual clinical practices and
source vendors is achieved by a network of secondary laboratories,
known as Accredited Dosimetry Calibration Laboratories (ADCL)
that are accredited and overseen by AAPM. For some sources,
including HDR 192Ir sources, ADCL maintains secondary standards
based upon NIST’s external-beam air-kerma standards. All clinical
brachytherapy sources shall have source strength calibrations that
are directly traceable to the primary or secondary air-kerma
strength standards maintained by NIST or ADCL when such stan-
dards exist. Creation of an appropriate primary or secondary
air-kerma strength standard should be considered as an essential
component of developing and clinically implementing new pho-
ton-emitting brachytherapy sources (Williamson et al., 1998).

4.2.2 Determination of Absorbed Dose

In brachytherapy, computation and display of the dose distribu-


tion within and around the implanted volume is an essential ele-
ment of current practice standards. The process of calculating the
dose distribution for a patient implant is designated “treatment
planning” and usually relies on digital computers equipped with
specialized treatment planning software. The mathematical model
used to calculate absorbed-dose rate, given the source locations,
strengths, internal construction, and radionuclide is called the
“dose-calculation algorithm.”

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4.2 SOURCES, DELIVERY TECHNOLOGY, AND DOSIMETRY / 79

Because direct measurement of absorbed dose near brachyther-


apy sources is technically difficult, historical dose calculation algo-
rithms have been based on semi-empirical models. The most widely
used of these models is the isotropic point-source model described
by the following equation:

· μ en med T r
D r = S K ⎛ -----------⎞ -------- , (4.3)
⎝ ρ ⎠ air 2
r
where:
·
Dr = absorbed-dose rate (in cGy h–1) in a medium at a
μ med distance r (in centimeters) from the point source
⎛ -------
en⎞
- = mass-energy absorption coefficient ratio used to con-
⎝ ρ ⎠air
vert air kerma to absorbed dose in the medium sur-
rounding the source.4

The factor, Tr is the ratio of the air kerma in the medium to that in
air at distance r from the source. It describes the effect of the sur-
rounding medium on absorbed-dose distribution and reflects the
competition between attenuation of primary photons and buildup
of scattered photons in the medium. For radium substitute radio-
nuclides, Tr is approximately equal to one for distances up to 5 cm.
The inverse square relationship, represented by the 1/r2 term, dom-
inates the absorbed-dose distribution. This simple one-dimensional
model is almost universally used for interstitial seed sources emit-
ting photons with energies >300 keV. This model was first general-
ized to extended sources (e.g., 137Cs intracavitary tubes and
needles) by Rolf Sievert in 1921 (Sievert, 1921). Reviews of this
model show that it accurately models 137Cs-source absorbed-dose
distributions but cannot be assumed to accurately predict absorbed
dose around lower energy sources (Williamson, 1996).
The simple analytic model described above is not sufficiently
accurate for clinical use in the 60 to 100 keV energy range or in
the 20 to 40 keV energy range of typical permanent implant
sources. Inaccurate dosimetry has been a serious barrier to accu-
mulation of consistent clinical experience with 125I permanent
implantation; the best estimate of the dose rate per apparent
millicurie at 1 cm has changed since its introduction in 1964
(Williamson, 1991b). In the last decade, low-energy brachytherapy
dosimetry has been placed on a firm foundation by validation and

4For
a more complete discussion on the relation between exposure and
various dose quantities, see Appendix A.1.

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acceptance of two quantitative dosimetry methods: use of ther-


moluminescent dosimeters and Monte-Carlo photon-transport
(MCPT) dosimetry calculations (Williamson, 1988; 1995; 1998).
The former method consists of placing thermoluminescent dosime-
ters, along with the brachytherapy source, into precisely machined
slots in a water-equivalent solid phantom. A multi-institutional,
National Cancer Institute sponsored research contract on low-
energy seed dosimetry demonstrated that low-energy source dose-
rate distributions could be reproducibly measured with a precision
of ±6 % (Anderson et al., 1990). This result encouraged clinical
acceptance of measured dose-rate distributions and stimulated fur-
ther research in this area. In contrast, MCPT simulation requires
a rigorous numerical solution of the Boltzmann transport equation,
which fully characterizes the absorbed-dose distribution in com-
plex systems of sources and applicators. Comparison of MCPT
calculations and thermoluminescent dosimeter measurements
showed excellent agreement (i.e., within 2 to 3 %, between the two
approaches) (Williamson, 1991b; 1994).
In order to facilitate clinical use of measured dose-rate distribu-
tions or those distributions derived from Monte-Carlo simulations,
AAPM (Nath et al., 1995) endorsed a new dose calculation formal-
ism specifically designed to use a sparse matrix of Monte Carlo or
measured dose rates as its input in contrast to the classical
semi-empirical models described by Equation 4.3. The formalism
uses tables of dosimetric ratios to account for various effects (e.g.,
radial dose functions to account for dose falloff along the transverse
axis and anisotropy functions to account for polar anisotropy). The
report of AAPM (Nath et al., 1995) recommends a critically
reviewed set of dosimetric parameters for two-dimensional dose-
distribution data for several models of 125I, 192Ir, and 103Pd seeds.
Various authors have published dose-rate distributions for other
sources using the format discussed in the report of AAPM (Das
et al., 1997; Williamson and Li, 1995). The semi-empirical dose
models and the AAPM calculations are in close agreement for 192Ir
and other radium substitutes but these models differ by as much as
15 % for 125I interstitial seeds.
Generalizations of the classical isotropic source models using
sievert methodology applied to the dosimetry of 137Cs tubes are also
sufficiently accurate for treatment planning purposes. For sources
having average photon energies <300 keV, transverse-axis dosime-
try should be based on carefully reviewed dose measurements or
Monte-Carlo simulations. In this energy range, classical models
should not be used for clinical dosimetry unless verified by Monte-
Carlo or experimental dose-estimation techniques.

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4.2.3 Physical and Dosimetric Properties of


Brachytherapy Sources
Some of the important properties of photon-emitting brachy-
therapy sources include photon energy and abundance, half-life,
specific activity, cost of production, toxicity and safety of the radio-
nuclide and its decay products. Photon energy is less important in
brachytherapy than in ERT. For sources emitting photons with
energies >100 keV, the inverse square law predicts transverse-axis
dose falloff within 5 % over the therapeutically significant distance
range from 0 to 5 cm (Williamson, 1998). Only for very-low-energy
sources (e.g., 103Pd and 125I) does the depth-dose curve significantly
deviate from the inverse square law. Moreover, absolute dose rate,
as well as relative dose, is independent of the radionuclide and
composition of the surrounding medium for sources emitting pho-
tons >200 keV (Williamson, 1998). This energy range includes all
of the reactor-produced radium substitute materials widely used
today in clinical brachytherapy. Low-energy photon sources, such
as 125I and 103Pd, produce dose-rate distributions that significantly
deviate from inverse square-law approximations, depend signifi-
cantly on the atomic composition of the surrounding tissue, and are
sensitive to small changes in photon spectrum. Even though pene-
tration in tissue is essentially independent of photon energy
>100 keV, the half-value layer in lead rises steeply with energy.
Because they have nearly identical depth-dose characteristics, arti-
ficial brachytherapy radionuclides with mean photon energies
>100 keV are often referred to as “radium substitutes.”

4.2.4 Sources for Low Dose-Rate Intracavitary Brachytherapy

Intracavitary therapy sources come in a variety of shapes and


sizes, are usually costly to fabricate, and may be used to treat
target tissue 2 to 5 cm from the applicator (Figure 4.1). The use of
long-lived radionuclides requires permanent encapsulation in a
nontoxic metal such as stainless steel or platinum. These sources
have approximate physical lengths from 20 to 25 mm, diameters
from 2 to 3 mm, and active lengths from 13 to 15 mm. They become
a part of an institution’s radionuclide inventory and will be used to
treat many patients over their useful half-life times. Tissue atten-
uation is one of the factors that limits the dose that can be delivered
to the periphery of the target volume. Radium-226, with its very
long half-life, was used for intracavitary treatment in the early
1900s, less than a decade after being isolated by Madame Curie.
The clinical use of radium has almost disappeared because of safety
hazards associated with the high-energy photons emitted by its

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82 / 4. BRACHYTHERAPY

daughter products as well as the gaseous physical state of


its immediate daughter product, 222Rn. Almost all modern LDR
intracavitary brachytherapy treatment is performed using 137Cs, a
fission byproduct with a 30 y half-life. Its single gamma ray of
0.66 MeV is less penetrating than the 0.8 MeV (average energy)
photons from radium and its decay products or the photons from
60
Co (Tables 4.1 and 4.2). Cesium-137 has solid decay products and
is normally distributed as insoluble glass microspheres encapsu-
lated in 0.5 to1.0 mm thick stainless steel. These sources produce
far less hazard in the rare circumstance of a ruptured source than
radium tubes but have dose distributions nearly identical to that of
226
Ra.
Originally, 1 Ci of activity was defined in terms of the rate of dis-
integration from one gram of 226Ra. This led to the widespread prac-
tice of specifying source loadings in terms of the milligrams of 226Ra
contained within the sources. Because all radium-substitute radio-
nuclides would have the same dose-rate constant, use of mgRaEq
units meant that 226Ra-loading rules could be applied unchanged
to implants using 137Cs or 192Ir. In LDR brachytherapy, the product
of source strength and treatment time was given in units of milli-
grams radium equivalent-hours (mgRaEq h). This term was widely
used to prescribe or describe intracavitary treatments. The quan-
tity corresponding to the product of SK and treatment time in
hours is referred to as the integrated reference air kerma (IRAK)
with units of μGy m2 (Williamson, 1993). Hence, 1 mgRaEq h =
7.23 Gy cm2. In terms of these quantities, intracavitary sources
have strengths ranging from 36 to 200 U, while the total air-kerma
strength loaded into LDR intracavitary applicators ranges from
130 to nearly 1,500 U. The IRAK per patient treatment ranges
from 80 to 400 Gy cm2. Treatment times vary from 18 to 75 h.
Virtually any surgically accessible body site with a well-defined
target volume can be treated with localized interstitial brachyther-
apy. Common sites for the use of this technique include localized
tumors of the breast, head and neck, gynecological and genito-
urinary systems, extremities, brain and various body lumina
including esophagus, biliary duct system and bronchi. Classically,
platinum-iridium clad 226Ra needles were implanted directly into
the target tissue. Cesium-137 needles replaced the use of radium
sources in the 1970s. Preloaded implant techniques expose all
surgical-suite personnel to ionizing radiation and can result in the
delivery of very high doses to the hands of the radiation oncologist.
For this reason, interstitial implantation of radium and radium
substitutes fell into disuse with the emergence of megavoltage
external-beam treatment machines.

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Interstitial brachytherapy experienced a renaissance in the


1960s when afterloading techniques using 192Ir sources were intro-
duced (Henschke et al., 1963; Pierquin, 1987). Iridium-192, with a 74 d
half-life and an average photon energy of 0.4 MeV, is a widely used
source for temporary interstitial implants. Although its average
energy is significantly lower than that of 226Ra, it produces
radium-equivalent absorbed-dose distributions in tissue and can be
cost-effectively generated in nuclear reactors to very high specific
activities. In Europe, 192Ir is often used in the form of a wire con-
taining an iridium-platinum radioactive core encased in a sheath
of platinum. In the United States, 192Ir is available in the form of
seeds (typically 0.5 mm in diameter by 3 mm long) with air-kerma
strengths of 1 to 72 cGy cm2 h–1. The seeds are encapsulated in a
0.5 mm diameter nylon ribbon and are usually spaced at 1 cm
center-to-center intervals. In addition to eliminating radiation
exposure hazards in the operating room, 192Ir ribbons and wires
can be trimmed to the appropriate active length for each catheter.
Typical loadings for interstitial implants range from 70 to 700 U
with treatment times from 24 to 168 h, and IRAK values from 50 to
250 Gy cm2. High specific activity 125I seeds are also used for tem-
porary interstitial implants. These sources are available in
strengths from 5 to 50 U. Although these sources are not dosimet-
rically equivalent to radium substitutes and present more biologi-
cal and dosimetric complexities than higher-energy sources, they
have several advantages. Because of the low-energy photons emit-
ted by 125I, a thin lead-foil shield or even tissue overlying the
implant site reduces ambient exposure rates dramatically, elimi-
nating or reducing potential radiation hazards to the attending
hospital staff or members of the public. In addition, thin high
atomic number foils may be used to internally shield critical struc-
tures near the implant site. The most common temporary implant
techniques are the use of 125I seeds for episcleral plaque-therapy for
intraocular melanoma, for retinoblastinoma, and for stereotacti-
cally guided brain implants. The thin (0.05 mm thick) titanium
capsule wall of 125I seeds can be ruptured by manual manipulation
and handling, potentially releasing radioiodine into the environ-
ment. All thinly encapsulated high activity interstitial sources con-
taining activity in a volatile form should be leak tested prior to each
use in a patient.

4.2.5 Sources for Permanent Interstitial Brachytherapy

For permanent implants, minimizing radiation exposure to the


general public has greatly influenced the choice of radionuclide.

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Classically, high-energy radionuclides with half-lives on the order


of a few days were used. Radon-222 gas encapsulated in gold tubing
and later 198Au seeds were used for permanent implants. The
patient had to be confined to a controlled area until source decay
reduced ambient exposures to acceptable levels. Such implants
used initial prescription dose rates of 0.7 to 1 Gy h–1 and delivered
most of the dose within one week, making them radiobiologically
similar to LDR temporary implants. Classical permanent implan-
tation techniques with 222Rn or 198Au delivered high doses to the
radiation oncologist’s hands and exposed inpatient hospital person-
nel to high-energy radiation.
Currently, longer-lived but very-low-energy photon emitters are
used for permanent implantation (i.e., 125I and 103Pd). A patient’s
own tissues or a thin lead foil are sufficient to limit exposure rates
to very-low levels. Use of these sources reduces exposure to the
radiation oncologist’s hands and fingers and eliminates the need
to hospitalize patients solely for radiation protection purposes.
The low initial-prescription dose rates characteristic of low-energy
seed implants, typically 0.03 to 0.2 Gy h–1, require delivery of doses
ranging from 100 to 145 Gy for definitive treatment as compared
to doses between 60 to 80 Gy for classical LDR implants.
Such implants are often described as “ultralow” dose rate. The
most common use of such sources has been for permanent implan-
tation in transperineal implantation of the prostate using transrec-
tal ultrasound imaging to guide seed placement (Blasko et al.,
1987). These procedures involve the use of 50 to 200 seeds with
source strengths from 0.4 to 3 U in order to achieve a minimum pre-
scribed dose up to 145 Gy for 125I seeds or up to 135 Gy for 103Pd
seeds as calculated according to AAPM (Nath et al., 1995) recom-
mendations.

4.2.6 Sources for High Dose-Rate Brachytherapy

Specific activity is an important source-selection criterion for


HDR brachytherapy as well as for highly miniaturized LDR inter-
stitial sources. Because of practical and theoretical limits on how
much 137Cs or 226Ra can be concentrated into a small pellet, these
radionuclides are not useful for HDR brachytherapy. Iridium-192
or 60Co, both of which have precursors with large neutron capture
cross sections and which can be produced with very high specific
activities, are the radionuclides commonly used for HDR brachy-
therapy. More detailed discussion of these sources will be found in
Section 4.3.4.

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4.2.7 Beta-Ray Applicators and Eye Plaques

Strontium-90 in the form of a sealed source may be used to treat


shallow lesions such as pterygium of the eye (Paryani et al., 1994).
Strontium-90 is a fission product, which decays to 90Y with a half-
life of 28.9 y, which in turn decays to stable 90Zr with a 64 h half-life.
The most common applicator is in the form of a handheld plaque
used to treat benign proliferative diseases of the eye. Surface dose
rates of ~1 Gy s–1 can be produced with 1.85 to 3.70 GBq (50 to
100 mCi) plaques. Some techniques for regional therapy are dis-
cussed in Section 3.
The use of plaques containing radioactive materials for tempo-
rary implants has been adapted for treatment of tumors of the eye
(e.g., retinoblastoma, choroidal melanoma, orbital rhabdomyosar-
coma, and ocular metastases from other cancers). The plaque is
sewn to the sclera, left in place for a calculated period of time and
then removed. The first radionuclide employed for this technique
was 60Co (Buys et al., 1983). Due to the high-energy emissions from
60
Co, placement of the plaque in close proximity to the optic nerve
had the potential to cause radiation-induced nerve damage. The
use of plaques with lower energy sources, chiefly 125I, reduced or
eliminated these complications and gave favorable clinical results
(Abramson et al., 1997; Melia et al., 2001). The lower energy
plaques also offered radiation safety advantages (Myers and
Abramson, 1988). More recently, plaques incorporating 106Ru have
found clinical acceptance and have been used in selected institu-
tions for treatment of choroidal melanoma and other diseases of the
eye (Georgopoulos et al., 2003; Murthy et al., 2005b).

4.2.8 Experimental Brachytherapy Sources

A number of radionuclides that emit low-energy photons in


the 40 to 100 keV range have been considered and investigated for
use in sealed-source brachytherapy. These include 169Yb, 241Am,
and 145Sm (Table 4.1) (Fairchild et al., 1987; ICRU, 2004; Mason
et al., 1992; Perera et al., 1994; Piermattei et al., 1992). The use of
131
Cs sealed sources for interstitial implantation in cancer therapy
was recently approved by FDA. In this photon energy range (4 to
34 keV), sources give rise to depth doses in tissue that are qualita-
tively similar to those of more conventional radium-substitute
radionuclides and, therefore, closely approximate inverse square-
law falloff. In contrast, 103Pd and 125I sealed sources with ultra-low
photon energies (20 and 28 keV, respectively) have depth-dose

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characteristics significantly less penetrating than those predicted


by inverse square-law models as discussed previously. The photons
emitted by 169Yb and 241Am sources, averaging 93 and 60 keV,
respectively, interact in water predominantly by elastic Compton
interactions, giving rise to multiply-scattered photons that
compensate for attenuation of the primary photons. However,
unlike photons emitted from higher-energy radionuclides, low-
energy photons interact by the photoelectric effect in lead and other
shielding materials, offering the prospect of effectively shielding
critical structures using individually-customized shields with thin
metallic foils, typically made of gold or platinum-iridium of 0.5 mm
thickness.
The use of 145Sm (x-ray energy of 43 keV) interstitial seeds,
encapsulated in titanium and having the same physical dimen-
sions as commercially-available 126I seeds, has been developed
as mentioned above (Fairchild et al., 1987). In addition to the
advantages of improved radiation protection and flexible internal
shielding design, investigators have proposed using 145Sm seeds to
treat tumors that selectively incorporate iodine-bearing thymidine
analogs into their deoxyribonucleic acid (Fairchild et al., 1982).
Samarium-145 emits photons just over the K-absorption edge of
iodine (33.2 keV) and releases an Auger electron cascade resulting
in a highly localized dose of moderately elevated linear energy
transfer (LET) radiation to the nuclei of tumor cells containing
iodine.

4.3 Treatment Delivery Technology

This Section presents an overview of some of the technology


used in applying brachytherapy techniques to various implant
sites. However, this Report cannot present an exhaustive discus-
sion of brachytherapy techniques. In particular, this Section is
intended to emphasize the radiation safety issues associated with
brachytherapy.

4.3.1 Permanent Implants

Permanent implants with either 198Au, 125I, or 103Pd seeds can be


performed in any surgically accessible body site. Tumor sites that
have been implanted include brain (meningiomas), lung, recurrent
head and neck cancer, retroperitoneal lymph nodes, and prostate.
Historically, implantation required surgical exposure of the target
area. Preoperative imaging and clinical examination are used to

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estimate the target-volume dimensions and the number and


strength of radioactive seeds needed to deliver the prescribed dose.
After surgically exposing the tumor, its dimensions are measured
directly and the proposed implant design reevaluated. Manual
calculation aids such as nomograms have been used to quickly
determine the seed spacings required (Anderson et al., 1993). Var-
ious types of single-seed implantation instruments, such as the
Mick Applicator® (Mick Radio-Nuclear Instruments, Inc., Mount
Vernon, New York), can be used to implant seeds one-by-one. Typi-
cally, preloaded cartridges containing from 10 to 15 seeds are
placed in the applicator. By ejecting each seed at a controlled
distance, a linear array of seeds can be approximated. Seeds can
also be placed using absorbable suture material containing from
5 to 10 seeds spaced at 1 cm intervals. These can be sutured
directly to the exposed tumor bed or sutured to a gel-foam sheet in
an array that is then sutured to the tumor bed. Linear arrays of
seeds contained within a semi-rigid absorbable suture material are
also available. The major radiation safety issues encountered with
the use of these seeds include minimizing exposure to the opera-
tor’s hands, inventory control, and minimizing large dose-delivery
errors.
The most common permanent implant procedure is the trans-
perineal prostate implant using transrectal ultrasound guidance
(Blasko et al., 1987; Holm et al., 1983). A template with a rectangu-
lar array of holes is used to guide the perineal implant needles. The
template may be rigidly mounted to the ultrasound probe. Usually,
a pretreatment ultrasound examination, or “volume” study, of the
patient in the treatment position has been performed. The trans-
verse images are contoured to form a three-dimensional model of
the target volume, anterior rectal wall, and urethra. These data are
then downloaded into a treatment-planning computer. Treatment
planning is used to optimize the needle locations, depths and load-
ing sequence of radioactive seeds and spacers needed to achieve
acceptable dosimetric coverage of the prostate and normal tissue
sparing. On the day of treatment, the patient is immobilized and
the volume study repeated. Under ultrasound guidance, the nee-
dles are positioned in as close an approximation as possible to the
preoperative treatment plan. Following completion of the proce-
dure, CT imaging is used to localize the seeds and delineate the
prostate. The dose distribution is then recalculated to evaluate the
technical success of the procedure. Transrectal ultrasound guided
perineal implant procedures require meticulous attention to QA
and accuracy of treatment planning and delivery to avoid large
dose-delivery errors.

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4.3.2 Manual Afterloading

Manually afterloaded intracavitary applicators were introduced


into clinical practice in the early 1960s. The techniques for manual
afterloading were first used as a replacement for radium-loaded
applicators in gynecological applications. The more common
applicators use a central intrauterine tandem and two vaginal
colpostats positioned within the vagina. The vaginal colpostats
may contain bladder and rectal shields with 3 to 5 mm thick tung-
sten alloy in the medial aspects of their anterior and posterior sur-
faces. The applicators are equipped with source holders for
inserting tube sources or identical size dummy sources. A sequence
(typically from two to six) of intracavitary sources can be loaded in
tandem into the intrauterine region by means of a thin flexible
plastic tube. To avoid exposure hazards, dummy sources are after-
loaded into the applicators to permit radiographic examination of
the implant. After the patient has been returned to her room, the
prescribed radioactive sources are manually afterloaded into
the applicator using handheld forceps and other tools for manipu-
lating the sources.
Afterloading techniques can also be used for accessible body
sites where catheters can be placed. Such sites include single
nodes, brain cancers, head and neck cancers, and limbs. In the
operating room, large trocar needles are used to implant flexible
nylon catheters that will later hold 192Ir ribbons. Typically, the
patient remains hospitalized for 3 to 5 d after the operative proce-
dure and before implantation to allow for wound healing. “Dummy”
(i.e., nonradioactive) ribbons are used to determine the location and
length of ribbon to be inserted in each catheter and the dummy rib-
bons remain in place until imaging of the implant is complete. The
dummy seeds are removed and the 192Ir seeds in ribbons are then
prepared. The patient is transported to his or her room and the 192Ir
ribbons are manually inserted. The ribbons are held in place by
placing small metal buttons over the ends of the catheters and
crimping these in place. Alternatively, the ends of each catheter can
be heat sealed. Procedures can use either “double ended” flexible
catheters, that require fixation at both the distal and proximal skin
surfaces, or a variety of single-ended (often called “blind-ended”)
applicators, requiring fixation only at the proximal skin surface.
Materials used include rigid steel needles as well as flexible plastic
catheters. Manually afterloaded 192Ir ribbons can be adapted for
use in fixed-source train (Figure 4.1) or multiple-channel remote
afterloading devices (Grigsby, 1992; Porter et al., 1988).

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4.3.3 Low Dose-Rate Brachytherapy Remote


Afterloading Systems

Remote afterloading systems robotically transfer sources from a


shielded storage container (or safe) to applicators in the patient
(Glasgow, 1993; 1995a). The device is connected to patient applica-
tors via transfer tubes and transports sources either by means of
stepping-motor driven cables or compressed air. These devices are
controlled by a separate control panel located near but outside
the room door. This location allows nurses to retract the sources
before entering the room to render care and to resume treatment
after completing each nursing intervention. The devices then dis-
play the remaining treatment time along with the status of the
machine. Generally, an LDR remote afterloader automatically
retracts the sources after the programmed cumulative treatment
time has elapsed. Conventional remote afterloading systems utilize
multiple sources that are simultaneously transported to each
applicator and remain continuously in their treatment positions
unless the treatment is interrupted. The source strength and radi-
onuclide loaded into the patient, the total treatment time pre-
scribed, and total IRAK delivered are identical to a corresponding
manually afterloaded treatment. Any room in a facility that is des-
ignated as adequate by the RSO for treatment using LDR tech-
niques should also be adequately shielded to accept an LDR remote
afterloader. Modifications will need to be made to accept the elec-
tronic controls and cabling for the afterloader. The device will also
need to be stored in a secure area when not in use. This area can be
within the treatment room or in an adjacent space. The major radi-
ation protection advantage of LDR remote afterloading is the
reduction of exposure to nursing and other inpatient personnel who
attend the patient.
The most common form of source used for LDR remotely after-
loaded intracavitary implants is 137Cs in the form of spherical pel-
lets. Each applicator of the programmable source-train device
consists of fixed treatment positions, each of which can be occupied
by a spacer or radioactive source allowing the user to program any
desired sequence of nonradioactive and radioactive pellets. The
radioactive sources and spacers are stored in separate compart-
ments of the main safe. Through a system of mechanical valves,
user-programmed sequences are assembled (composed) and placed
in the intermediate safe compartment coupled to the corresponding
applicator. Compressed air is used to pneumatically transport
the assembled source trains from the intermediate safe to the
applicator and automatically return them to the intermediate safe

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90 / 4. BRACHYTHERAPY

on completion of the programmed treatment time or when inter-


rupted by an operator. This design has been adapted to HDR
devices.

4.3.4 High Dose-Rate Brachytherapy Remote


Afterloading Systems

High dose-rate (HDR) brachytherapy blends traditional intrac-


avitary, interstitial and transluminal dose delivery strategies with
external beam-like instantaneous dose rates, outpatient treatment
orientation, and dose-time-fractionation philosophy. A common
model of remote afterloader uses 192Ir source. Programmable
source-train machines, using multiple high-intensity 60Co spheres,
are also available for intracavitary HDR brachytherapy (Chenery
et al., 1985). Because the instantaneous dose rate is large (as much
as 450 Gy h–1 at 1 cm), carefully crafted safety and QA programs
are essential. The outpatient character of HDR brachytherapy cre-
ates an additional safety hazard (i.e., all complex series of tasks
must be completed in a single, short time period).
The latest generation of remote afterloaders are single-
stepping source devices using high intensity 192Ir sources (SK =
4 × 104 cGy cm2 h–1) (Glasgow et al., 1993; 1995a). A single source,
available with external diameters from 0.6 to 1.1 mm and lengths
from 4 to 12 mm is located at the end of a drive cable or wire which
sequentially stops at each preprogrammed treatment position, or
“dwell” position, for a programmed treatment or “dwell-time” from
1 s to several minutes depending on the application. These systems
can inject the source cable into as many as 24 treatment channels
that communicate by means of transfer tubes connecting each
applicator to the appropriate channel port on the machine. Unlike
conventional manually or remotely afterloaded implants, which
simultaneously treat all active source positions, a single-stepping
source afterloader treats one dwell position at a time, by sequen-
tially transporting the source to each implanted catheter, treating
the programmed positions in sequence, retracting the source into
the machine, inserting it into the next applicator, and repeating the
process.
Because HDR brachytherapy is an outpatient modality, patient
convenience is enhanced and there is a potential to reduce costs by
eliminating the need to hospitalize many patients. Radiation expo-
sure to personnel is almost completely eliminated. Finally, HDR
brachytherapy offers the ultimate in technical flexibility, as each
dwell position can be placed anywhere along the catheter track
and its dwell-time programmed individually. Treatment planning

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software capable of optimizing target-volume coverage or dose uni-


formity through automated manipulation of the dwell-time distri-
bution is offered by all major vendors.
The increased complexity, compression of time for planning and
treatment delivery processes and rapid delivery of high-dose frac-
tions characteristic of HDR brachytherapy create opportunities
for serious treatment delivery errors (Thomadsen et al., 2003).
This modality requires a well-organized procedure, a larger techni-
cal staff, and a more complex and comprehensive QA program
(Appendix C).

4.3.5 “Pulsed” Dose-Rate Remote Afterloading Systems

The pulsed dose-rate (PDR) remote afterloader is a relatively


recent device that combines the single-stepping source technology,
characteristic of HDR brachytherapy, with conventional inpatient-
based LDR brachytherapy (Williamson et al., 1995). One commer-
cially available device uses a single 37 GBq (1 Ci) 192Ir source
welded to the end of a transfer cable to sequentially treat each
dwell position. This device simulates continuous LDR brachyther-
apy by automatically administering a sequence of “mini” HDR frac-
tions, generally at hourly intervals such that the average hourly
dose rate is the same as that of the corresponding manually after-
loaded treatment. Such fractions are described as “pulses” and
the interval between successive pulses, during which the source
remains in its shielded safe, is the “quiescent” period. In all other
respects, PDR brachytherapy is identical to LDR brachytherapy.
Patients must be hospitalized during the procedure and dose pre-
scriptions and total treatment times are unchanged. In contrast to
conventional remote afterloading technology, PDR brachytherapy
supports:

• improvement of implant quality through manipulation of


individual dwell-times;
• improved flexibility in choosing prescription dose rates by
varying the pulse width unlimited by either source decay or
a finite source inventory; and
• reduction in the overall time for the implant by confining
nursing interventions to the quiescent periods.

A PDR system uses a single moving source with an instanta-


neous tissue dose rate as high as 45 Gy h–1 at 1 cm. If a PDR after-
loader malfunctions and fails to retract the source from the patient,
serious patient injury and large staff exposures could result if the

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92 / 4. BRACHYTHERAPY

source is not rapidly brought under control. In contrast, with con-


ventional LDR systems, a source retraction failure would result in
continuing dose delivery. Finally, use of the PDR system greatly
increases the complexity of machine acceptance testing and QA, as
well as implementation of individual patient procedures.

4.4 Specific Precautions and Procedures

This Section discusses specific precautions and procedures nec-


essary for each type of brachytherapy procedure. This Section is not
a substitute for information developed by other voluntary and sci-
entific organizations that address clinical or medical-physics issues
in more detail. This discussion provides a general overview of the
types of precautions and procedures necessary for good radiation
safety practice and addresses broadly the general state of practice.

4.4.1 Manual Afterloading

Manually afterloaded sources should always be handled utiliz-


ing radiation safety precautions that minimize whole-body and
extremity exposure. Remote handling devices (e.g., long-handled
forceps) should always be used. Shielded workstations shall be
available for source preparation and calibration.
Prior to applicator insertion and source loading, patients should
be thoroughly informed regarding the nature of the procedure, any
anticipated acute symptoms or complications, and any procedures
or restrictions they may be expected to follow in order to maintain
the integrity of their implant. The patient should also be informed
of any restrictions that may be necessary for the safety of staff, vis-
itors and other patients. Patients should understand clearly any
limitations on ambulation, number and types of visitors, and limits
on visitation time. If by virtue of impaired mental or medical con-
dition, compliance with these instructions cannot be expected,
appropriate use of medication and intensive observation by nurs-
ing staff should be considered. In a rare circumstance, the radia-
tion oncologist may need to consider whether alternative treatment
would better suit the patient.
Before removing brachytherapy sources from the source prepa-
ration area, the destination, patient identifier and hospital room,
the strength, number and type of sources removed shall be
recorded. The inventory of remaining sources should be reviewed
and checked for consistency with the number of sources possessed
by the institution and other sources in use. The strength and iden-
tity of the sources shall be verified prior to loading sources into the

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4.4 SPECIFIC PRECAUTIONS AND PROCEDURES / 93

patient. This can be achieved by visually checking source serial


numbers or strength-specific color codes. Sources shall be trans-
ported from the preparation area to the patient room in a shielded
container labeled with a “radioactive materials” label indicating
the type, number and strength of sources being transported.
Before loading radioactive sources into a patient, the patient’s
identity shall be confirmed and matched for consistency with the
written prescription by two independent means. A wristband bear-
ing the information “radioactive precautions” should be placed on
the patient. A minimum of two individuals should participate in
the loading of radioactive sources. One person should be assigned
the task of verifying the loading sequence against the written
prescription. During the loading process, the prescription shall be
available and the identity of each source or source train checked as
it is loaded into the appropriate applicator or catheter. Sources
remaining in the transport container should be counted and
returned to the inventory. A logbook should be maintained of all
sources taken out of and returned to the inventory.
After sources are loaded, the following actions or procedures
should be in place:

1. The date and time of source insertion shall be documented


on the prescription along with the anticipated date and
time of source removal. Copies of the prescription should
be placed on or within the patient's chart. The exterior of
the patient’s chart should be labeled with the standard
radiation symbol and with the measured exposure rates. If
the chart is electronic, provision should be made for infor-
mation on radiation precautions to appear in some man-
ner each time the chart is accessed during the period when
the implant is in place.
2. The room should be posted with signs, “caution radioactive
materials,” as well as posted as a “radiation area.” Also,
information for visitors should be posted.
3. The exposure rate, air kerma rate, or dose rate shall be
determined at a standard distance, such as 1 m from the
approximate center of the implant in the patient with an
appropriately calibrated survey meter, such as a portable
ion chamber. When in the judgment of the RSO the use of
portable shielding is deemed necessary, measurements at
the doorway and in any surrounding areas protected by
portable shields should be made and recorded in the radia-
tion safety log, whether manually or electronically, to
insure correct placement. The total exposures to medical

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94 / 4. BRACHYTHERAPY

personnel or any unsupervised individuals, including visi-


tors, over the life of the implant should be assessed for
consistency with the facility’s ALARA program.
4. Written orders pertaining to radiological and patient
safety shall be available including special procedures (e.g.,
closure or restriction of surrounding rooms) required to
satisfy ALARA dose limits.

For each procedure, a method should be developed for medical


personnel to check the integrity and position of the implant. Writ-
ten nursing procedures, specific for the implant type, should be
immediately available on the inpatient unit. These procedures
should include emergency procedures, access control, and recogni-
tion of source positioning. Before 50 % of the dose is delivered, the
manual or computer assisted calculations used to determine
the treatment time and source loading needed to fulfill the written
prescription shall be independently reviewed. The individual ini-
tially preparing the calculations and the reviewer should be a qual-
ified medical physicist.

4.4.2 Patient Care Precautions During Treatment


Inpatient nursing staff shall control access to brachytherapy
treatment rooms by healthcare personnel not involved in the treat-
ment and by the public. Nursing personnel are responsible for
ensuring compliance with restrictions defined in the patient’s
chart. Medical personnel should check the integrity of the implant
at intervals specified by the responsible radiation oncologist.
A radiation oncologist or other physician with appropriate med-
ical and radiation safety training shall be available on an on-call
basis at all times while brachytherapy treatments are in progress.
Also, a medical physicist or medical health physicist should be
available. Nurses shall notify these individuals promptly in the
event of missing or displaced sources, significant changes in
implant position, or any other circumstance that may threaten the
safety of personnel, the public, or the patient and may jeopardize
the delivery of the planned dose. Procedures for dealing with dis-
lodged sources should be part of the nursing manual. A shielded
container and tools for the remote handling of a source, source
train, or applicator containing sources shall remain in the patient’s
room for the duration of the implant. This container should
be of sufficient size and shielding to safely hold any sources that
could become accidentally dislodged. If the individual responsible
for removing the sources fails to appear at the designated time,

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4.4 SPECIFIC PRECAUTIONS AND PROCEDURES / 95

nursing personnel shall contact the responsible radiation oncologist


or on-call physician. Modifications to the source loading or implant
duration should be noted in writing on the written prescription
including the copy posted in the patient’s chart. Linens, food, uten-
sils, trash and excreta are not contaminated. However, linens and
trash should remain in the room until surveyed to ensure that no
displaced sources are present. Any special circumstances should be
clearly noted in the radiation-oncologist’s orders or the proce-
dure-specific nursing instructions in the nursing manual.

4.4.3 Patient Care Precautions During Source Removal

Surgical dressings and bandages near the implanted applica-


tors or sources shall be removed carefully and checked by the radi-
ation oncologist, or other appropriately trained medical staff,
taking care not to dislodge the implant. Individuals responsible for
changing such dressings should have training in source recogni-
tion, source-handling procedures, basic radiation safety proce-
dures, and ability to assess correct implant position and integrity.
Sources and applicators shall be removed by an appropriately
trained individual, preferably the radiation oncologist. Any
required pain medication should be ordered at a time sufficiently
in advance of the unloading so that the procedure is not compro-
mised. Sources shall be removed using a remote handling device
and placed immediately into a shielded container. The date and
time of source removal shall be documented on the prescription or
treatment record and in the patient's chart. As the sources are
being removed, the physician shall count the number of intra-
cavitary sources or interstitial ribbons removed to verify that all
sources documented on the written prescription have been
removed.
After removal of the sources from the patient’s room, a careful
survey of the patient, the treatment room, and removed applicators
shall be performed using an appropriate survey meter (e.g., a GM
detector) and the results documented in the treatment record, radi-
ation safety log, and in the patient's chart. The treatment room
shall not be released for cleaning and occupancy by another patient
until:

• the sources are removed from the room and secured;


• the number of sources removed is reconciled with the num-
ber known to have been loaded; and
• the radiation survey verifies that no sources remain in the
room.

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96 / 4. BRACHYTHERAPY

The sources should be promptly returned to the source prepara-


tion area where a second source-by-source (seed-by-seed) count
should be performed. Following this count, the sources should be
returned to their permanent storage location, and the number of
sources in that safe or storage receptacle checked for consistency
with the relevant number of sources possessed by the institution,
including those in use for other purposes. Cleaning or sterilization
of surgical equipment should only be performed after a survey dem-
onstrates that there is no residual activity. In the unusual circum-
stance that it becomes necessary to leave the sources in a patient
room, the container should be made secure against unauthorized
access or removal and properly labeled. In such circumstances, the
nursing staff shall continue to treat the room as a restricted area.
If a source appears to be lost, the responsible radiation oncologist,
medical physicist and RSO shall be contacted immediately and the
patient’s room secured.

4.4.4 Low Dose-Rate Remote Afterloading

Within 24 h of initiating an LDR remotely afterloaded treat-


ment, the correct operation of the system and its ancillary
safety devices shall be confirmed by performing standardized daily
QA tests (Appendix C). The individual programming the remote
afterloader shall have available the written prescription or treat-
ment plan defining the prescribed sequence of sources and
treatment times in each channel.
Prior to initiating treatment, the setup and afterloading pro-
gram shall be independently checked. The correct correspondence
and connection of programmed channels and implanted applicators
should be confirmed. This check of the initial programming and
patient setup should be performed by a qualified medical physicist
and radiation oncologist. During treatment, a radiation oncologist
and a qualified medical physicist should be available on-call at all
times. The qualified medical physicist should be skilled in after-
loader operation and management of emergency or malfunction
conditions.
As the treatment room is entered, the sources shall automati-
cally retract. This withdrawal will result from the interruption of
an interlock switch located on the treatment room door. The room
shall also be provided with an area monitor that will indicate the
presence or absence of radiation to persons entering the treatment
room. To avoid prolonging the treatment, interruptions and visits
to the patient should be minimized. Whenever the treatment is
interrupted, the treatment room door shall remain open. To avoid

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4.4 SPECIFIC PRECAUTIONS AND PROCEDURES / 97

unintentional irradiation of visitors and staff, operators shall visu-


ally confirm that the treatment room is occupied only by the
patient before resuming treatment.
Should the area monitor or treatment device indicate a source
retraction failure at the end of treatment or following an interrup-
tion command, the responsible medical physicist shall be informed
immediately. Malfunctions of the afterloader or its ancillary safety
systems shall be brought to the immediate attention of the on-call
radiation oncologist and medical physicist.
Until the sources are brought under control, nursing staff shall
practice appropriate manual afterloading safety precautions. Nurs-
ing staff and the responsible medical physicist shall follow docu-
mented emergency procedures. Staff shall be trained in emergency
procedures during the initial installation of the device and at
annual intervals thereafter. Following completion of treatment, a
careful survey of the patient, the treatment room, removed appli-
cators, and the afterloading housing shall be performed using a cal-
ibrated survey meter (e.g., GM detector) to confirm complete
retraction of the sources. The results shall be documented in
the patient’s treatment record. The treatment room shall not be
released for cleaning and occupancy by another patient until the
radiation survey is complete and is negative for incompletely
retracted sources.

4.4.5 High Dose-Rate Remote Afterloading

High dose-rate (HDR) brachytherapy is typically performed


as an outpatient procedure with daily dose fractions ranging from
2 to 10 Gy delivered in a few minutes using high intensity sources
with instantaneous dose rates as high as 4.6 × 104 cGy cm2 h–1. The
combination of large dose fractions, short time frames, intense
pressure on personnel, enhanced technical flexibility, and complex-
ity of treatment planning and delivery devices creates potential
opportunities for treatment-delivery errors. Because of the high
doses per treatment fraction and small number of fractions com-
pared with typical ERT, recovery from errors is difficult and the
consequences of error are potentially significant. A well-organized
and well-trained treatment-delivery team (radiation oncologist,
medical physicist, dosimetrist, and therapist) is essential. The need
for detailed written procedures, checklists, written communication,
and personnel training is especially critical in HDR brachytherapy.
Various groups have developed comprehensive protocols for devel-
oping and maintaining safe treatment delivery processes (Kubo
et al., 1998; Kutcher et al., 1994; Nath et al., 1997).

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98 / 4. BRACHYTHERAPY

4.4.5.1 Organization of the Treatment Delivery. At a minimum,


there are four essential participants on the team: the radiation
oncologist, the medical physicist, the dosimetrist, and the treat-
ment unit operator, usually a radiation therapist. A successful pro-
gram shall require a well-qualified and integrated treatment-
delivery team with substantially more expertise than that afforded
by formal certification processes. The additional expertise,
required above and beyond board certification, is usually acquired
through training by the device manufacturer, focused self-study,
careful planning and preparation, extensive practice with the
devices either onsite or at a participating facility, and visits to
established HDR brachytherapy programs (Callan et al., 1995).
Computerized treatment planning shall be available for
HDR treatments. At a minimum, each institution providing HDR
brachytherapy shall develop written treatment procedures
defining:

• the step-by-step sequence by which the procedure is per-


formed including the critical duties of each team member;
• information to be captured at each step and how it is to be
recorded; and
• critical actions and decision points where a redundant QA
check is needed.

4.4.5.2 Documentation Requirements. Accurate HDR treatment


planning and delivery requires accurate information transfer
among delivery team members working in the operating room, the
simulator room, and the treatment-planning and -delivery areas.
The radiation oncologist, medical physicist, dosimetrist, and ther-
apist should cooperate closely and communicate accurately and
unambiguously. All critical information, including applicator types
used, relation of target volume to applicators, dose prescription,
and simulator localization data shall be recorded on appropriate
forms by individual team members primarily responsible for each
corresponding activity. This form should accompany the patient
chart and treatment folder as the patient proceeds through appli-
cator insertion, treatment planning and treatment delivery. Each
facility should develop forms for the following functions:

• written prescription and daily treatment record;


• daily remote afterloader QA protocol;
• physicist’s treatment plan and documentation review; and
• documentation of implant geometry, simulation data, and
verification of computerized dwell-time calculations.

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4.4 SPECIFIC PRECAUTIONS AND PROCEDURES / 99

No form is more critical to the safe execution of HDR brachy-


therapy than the treatment prescription and daily treatment
record. This form functions as an overall summary of the multi-
fraction course of therapy, including the current status of treat-
ment (total dose and number of fractions given) and the written
prescription. Manual or computer assisted calculations used to
determine the dose delivered should be included in the patient’s
chart and separately in a treatment folder depending on the type of
facility. The individual initially preparing the calculations or the
reviewer should be a qualified medical physicist. More detailed
descriptions of individual fractions (e.g., dwell-time distributions)
should be filed in separate sections of the chart. This form should
be brief and general so that critical questions can be quickly
answered.
Each facility shall develop a clearly defined prescription form
documenting:

• fraction size;
• number of fractions;
• total dose;
• dose specification criteria;
• radiation oncologist’s signature and date;
• location of the active dwell positions or applicator system
relative to the written prescription;
• the identity of the applicator system; and
• the identity of the remote afterloader including some spe-
cific identification system if more than one unit is available.

The daily treatment record shall show the date and dose of each
fraction delivered, the cumulative total dose, the source strength,
total dwell-time, and applicator system used.
All detailed documentation specific to each fraction should be
filed in a clearly marked section in the chart. All forms shall con-
tain the patient's name and date of treatment. At a minimum, the
chart and treatment folder shall include a detailed implant dia-
gram, documenting the correspondence between catheter (channel)
numbering system relative to external anatomy and radiographic
images of each catheter, and also the graphic treatment plan (e.g.,
isodose plots) or other calculations used as the basis of remote-
afterloader programming.

4.4.5.3 Treatment Specific Quality-Assurance Recommendations.


A detailed discussion of quality-assurance (QA) recommendations
is beyond the scope of this Report. Recommendations on the type of

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100 / 4. BRACHYTHERAPY

QA checks that may be performed are given in Appendix C and in


the reports published by the American College of Radiology, the
American Association of Physicists in Medicine, and the American
College of Medical Physics. These recommendations are supple-
mental to the recommendations of the manufacturer and may be
less specific than those procedures recommended by the profes-
sional organizations mentioned above.
In this Section, emphasis has been placed upon positional accu-
racy. A significant percentage of reported treatment delivery errors
involve programming of incorrect positions into the treatment
device that result in administration of treatment to the wrong site.
This problem is due to the large number of variables (e.g., calcula-
tion of dwell-times, entry of wrong activity or data, verification of
patient identity) needed to support the increased positional flexi-
bility of single-stepping source machines. The calculations needed
to derive these parameters are simple but shall be verified (Ezzell,
1995). As most single-stepping source machines have no interlocks
to prevent applicator-channel mismatches, only redundant manual
checks can exclude delivery of dwell position sequences to the
wrong applicator. When the dwell-time is derived from manual
calculations, they shall be reviewed by a second individual not
involved in the initial calculation. When the dwell-time is calcu-
lated by the treatment planning computer program, an indepen-
dent manual- or computer-based (using different software and
operator) calculation shall be performed. If the physicist performs
the treatment planning, or works closely with a dosimetrist, a third
person uninvolved in the original planning should review the
dwell-time and source position calculations. The review process
should be reviewed and signed by a qualified medical physicist
(Neblett and Wesick, 1995; Van Dyke et al., 1993). The qualified
medical physicist should also review all treatment parameters,
including data entry from radiographs or other imaging systems.
Upon completion of an HDR treatment or whenever treatment
is interrupted, complete source retraction shall be confirmed both
by means of the area monitor or by a handheld survey instrument.
The survey instrument should be selected carefully so that the
instrument does not saturate in high radiation fields. The selected
instrument shall be checked for an appropriate response near the
exposed HDR source well in advance of the patient treatment. If
false readings in high-intensity fields could occur, an ion chamber
survey meter should be used to cover the upper extreme of the
exposure-rate range. Before each treatment the physicist’s QA
checks shall include checks of the functioning of radiation
detectors.

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4.5 HIGH DOSE-RATE EMERGENCY PROCEDURES / 101

4.5 High Dose-Rate Emergency Procedures


and Treatment Attendance Requirements

Significant radiation injury could result from an HDR source


becoming detached from its cable during treatment or if it failed to
retract. Several investigations have focused on these issues (NRC,
1993a; 1993b; Thomadsen, 1995). Fortunately, the incidence of
these dangerous events seems to be quite small and the failure
of source retraction is considered highly unlikely. Despite the low
probability of this event, all institutions practicing HDR brachy-
therapy shall develop appropriate emergency procedures for rap-
idly bringing an unretracted source under control and shall train
staff in them. Such procedures shall also address emergency
removal of the applicator system from the patient.
It should be assumed that a source retraction failure exists
under any of the following conditions:

• the area monitor indicates a radiation field when the HDR


system is interrupted;
• an error condition, as indicated by a code number consistent
with source-retraction failure, appears on the console; and
• a portable survey meter indicates a radiation field during
treatment-interrupt status.

Any of the above conditions should result in the following immedi-


ate emergency actions on the part of the physicist and the operator:

1. The physicist should interrupt the use of the HDR unit


and activate the emergency retraction system available at
the console.
2. The physicist should enter the room with a portable sur-
vey meter to verify the existence of a source retraction fail-
ure. If the source is not completely retracted, the physicist
should activate the emergency retraction drive using the
control system inside the treatment room.
3. If the survey indicates that radiation continues to be
present, the physicist should manually retract the source.
4. If radiation is still present and the implant is designated
“easily removable,” the radiation oncologist should remove
the applicators, secure them in the emergency shielded
container, and verify that the patient is free of radioactive
sources.
5. If the implant is not easily removable, the radiation oncol-
ogist should disconnect the transfer tubes from the

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102 / 4. BRACHYTHERAPY

indexer, extract the source cable from the applicator, place


the source cable intact into the shielded source holder, a
so-called “bail out box” within the treatment room, and
remove the patient from the room. If this procedure is
not possible, the source should be moved away from the
patient, the cable should be cut, and the distal cable frag-
ment secured in a shielded storage container.
6. If radioactive material remains in the patient, the physi-
cist and radiation oncologist should seal the proximal ends
of the applicators, remove the applicators, and secure
them in a shielded container.

These conditions require that the physicist and radiation oncol-


ogist carefully think through the process of applicator removal for
all temporary implants including difficult interstitial implants
(e.g., base of tongue) and develop detailed written procedures
for removing the catheters (Thomadsen, 1995). These emergency
procedures should be practiced in dry runs at least once a year by
all persons likely to be involved in patient treatment. The opera-
tor’s manual shall be available at the console whenever patient
treatment is performed. Some implant techniques, such as implan-
tation of sites inaccessible for catheter removal except in an oper-
ating room, may not be suitable for HDR brachytherapy if they are
overly complex or involve medically risky applicator removal tech-
niques. Under no conditions shall open-ended applicators that
allow a detached source to lodge interstitially in the patient's tis-
sues be used for HDR brachytherapy.
A medical physicist and an individual qualified to remove the
applicators from the patient under emergency conditions shall
attend all treatments and shall be prepared to detect emergency
conditions and implement the appropriate responses.

4.6 Addressable Events

In any use of brachytherapy techniques, there exists a potential


for radiation injury. It is essential that any deviation from estab-
lished techniques or procedures be addressed as rigorously as pos-
sible, whether a regulatory requirement or not. An addressable
event may be considered to be any clinical or technical event that
occurs in the course of planning, executing or managing a brachy-
therapy procedure that has a significant adverse effect on the
safety or efficacy of the procedure and that could have been avoided
by appropriate procedural changes.

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4.6 ADDRESSABLE EVENTS / 103

The following are examples of addressable events:

• use of a radionuclide or source type in a therapeutic proce-


dure other than the source or radionuclide prescribed;
• administration of a treatment or procedure to a patient
other than the intended patient;
• administration of a therapeutic dose to an area other than
the area prescribed;
• errors in computation, calibration, treatment time, source
placement, source strength, or equipment malfunction such
that the calculated total treatment dose delivered differs
from the final prescribed dose by >20 %;
• failure to account for effects on dose distribution of prior,
concurrent or subsequent radiation treatment, of medica-
tion(s), or of medical procedures that may compromise ther-
apeutic efficacy; and
• delivery of a therapeutic treatment dose in a single fraction
of a fractionated prescription such that the administered
dose in the individual treatment differs from the dose pre-
scribed for that individual treatment by >50 %.

The evaluation of an addressable event resulting from a brachy-


therapy procedure can be complex. A careful analysis of the cause
or causes should be performed. Complexities arise due to difficul-
ties in defining the treatment volume, specification of dose con-
tours, and evaluation of the prescription itself. The causal analysis
should address a review of the records of the procedure, review of
policies and procedures, consideration of equipment performance,
and training and education. The review team should be under the
direction of an individual experienced in such analyses who was not
involved in the procedure. The services of a qualified medical phys-
icist shall be available in the evaluation of an addressable event.
Services provided by the medical physicist shall include the evalu-
ation of the actual dose delivered and an evaluation of the proce-
dural systems in place. The medical physicist, radiation oncologist,
and RSO shall develop a plan of action to prevent future occur-
rences. Remediation, including further education of personnel as
appropriate or development of further safeguards should be imple-
mented. It is essential that a thorough review of pertinent policies
and procedures be performed to determine the cause of the event.
Federal and local regulatory agencies will have specific require-
ments regarding the reporting of medical events. These regulations
should be familiar to the RSO and the administration of the facility.

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104 / 4. BRACHYTHERAPY

Addressable events involving brachytherapy shall be reported


to the RSO and treating radiation oncologist as soon as these
events are discovered. The RSO in consultation with the treating
radiation oncologist and the administration of the facility can
then determine if these events meet regulatory standards for
reportability. These events should also be reported to the patient
and the referring physician as soon as possible, preferably within
one working day of the discovery. Doses shall be calculated to eval-
uate the doses to specific organs. The attending radiation oncolo-
gist should decide if there would be any expected medical
consequences of an event, either short- or long-term. Appropriate
interventions shall be considered in light of the patient’s overall
medical condition, the medical consequences of the event and the
effects of any intervention. Short- and long-term medical manage-
ment of such events should be planned carefully on an individual
basis.
Even if an addressable event results in no demonstrable harm
to the patient, it may represent a procedural lapse, a breakdown
in existing systems, or lead to the identification of systematic
problems that need to be addressed. Addressable events also may
result from human error. However, such a finding should require
consideration of factors that contribute to these errors, including
the workload of the individual, staffing issues, and the working
environment.

4.7 Readmission

When patients with permanent seed implants are admitted to


an inpatient facility, written nursing procedures specific for the
implant type should be immediately available on the inpatient
unit. If a patient is being readmitted for medical reasons, the facil-
ity should develop a system whereby patients who still contain
significant amounts of radioactive materials are recognized upon
admission. The RSO should be notified in these circumstances and
should provide instructions to staff and place radiation precautions
in the chart as necessary. Depending on the site implanted, it is
possible for seed(s) to be lost through urine, sputum or other body
excreta. These losses may occur while the patient is in the hospital
or after the patient is discharged. A common time when seeds may
be lost is during removal of catheters or drains, especially Foley
catheters. Clinical staff should be instructed in the recognition of
the types of seeds used by the facility. Any suspected loss of seeds
should be reported to the radiation safety staff and the responsible
radiation oncologist.

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4.7 READMISSION / 105

4.7.1 Inventory Control


A common problem with permanent implants has been verifica-
tion of the number of seeds used (Stutz et al., 2003). Before seeds
are used for implantation, a careful seed count should be performed
and entered into the source inventory log maintained by the facil-
ity. To avoid problems with seed sterilization, some facilities are
using prepackaged, sterile sources with a seed count verified by the
manufacturer. As the implant procedure progresses, it should be
possible for a member of the implant team (e.g., a physicist, resi-
dent or therapist) to independently verify the seed count. A mem-
ber of the surgical team should be assigned the task of counting
seeds or seed arrays as they are used. Before the radiation-oncology
team leaves the surgical area, the seed counts should be verified. If
there is a discrepancy in the count, radiation safety staff should be
notified and the room should be checked for any seeds that may
be lost in the surgical area. These checks may be performed using
portable survey meters, such as GM counters or sodium-iodide
[Nal (Tl)] scintillation survey meters. If no seeds are found in the
surgical area, it is possible that the count has not been kept cor-
rectly. Seeds not used should be promptly returned to the source
preparation area where a seed-by-seed count should be performed
to verify the seed count. If a CT scan is performed on the patient
post-implant and predischarge, the CT scan may be used as a fur-
ther verification of the seed count if a discrepancy still exists. The
source custodian should record the number of seeds used and
the number of seeds returned and verify the accuracy of the seed
count.

4.7.2 General Radiation Safety Procedures

Following completion of the surgical procedure, whether on an


inpatient or outpatient basis, a member of the implant team shall
measure the radiation exposure from the patient on the surface of
the patient’s body and at 1 m from the approximate center of the
implant. These measurements shall be made using a calibrated
ionization chamber survey meter. These readings shall be entered
into “radiation-precaution” tags placed in the patient’s chart. The
tags shall also indicate the date on which radiation precautions are
no longer necessary. Because both 125I and 103Pd emit low-energy
photons that are readily absorbed in tissue, the amount of overly-
ing tissue will usually influence the exposure rate. A radiation sur-
vey of the operating room shall be performed by a member of the
implant team using a sensitive survey meter (e.g., a scintillation
detector) to confirm that no radiation sources are left in the room

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or in materials from the procedure before room cleaning can be


started.
Prior to release of either the inpatient or outpatient setting, the
attending radiation oncologist, medical physicist or RSO shall
provide the patient with radiation precautions appropriate to his
individual circumstances. These instructions shall include the pos-
sibility of the loss of seeds, importance of maintaining distance, and
special care with regard to minors. A record of this interview
should be part of the radiation safety record. Prior to discharge,
patients should be supplied with a document verifying the specifics
of the implant as well as with information for contact with the
department (Dauer et al., 2004; Smathers et al., 1999). The contact
information should include a telephone number that will allow
patients to call for response to any questions arising post-implant
as well as a number for questions from authorities in the event that
the presence of the patient activates radiation detectors installed
in public access areas or transportation checkpoints.

4.8 Emergency/Off-Hours Response

A list of names and 24 h telephone numbers of individuals to


contact in the event of a radiation emergency shall be available.
This list is separate in function from listings of persons responding
to radiation disasters or emergencies in emergency rooms or
trauma centers. Personnel to be contacted may include the RSO
and the responsible radiation oncologist or the radiation-oncology
resident or fellow on-call. These lists shall be available to medical
personnel caring for the patient. Specific instructions for emer-
gency situations are given in Section 6.

4.9 Other Applications

This Section is intended to describe some new areas of develop-


ment in brachytherapy sources and in the use of brachytherapy
techniques.

4.9.1 Intravascular Brachytherapy

Percutaneous transluminal balloon angioplasty (PTA) is an


important method of treating both peripheral and coronary artery
disease in which case PTA is called percutaneous transluminal
coronary angioplasty (PTCA). The primary complication following
either PTCA or PTA is restenosis, a narrowing of the arterial lumen
in response to injury inflicted on the vessel by the procedure

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required. Estimates of the incidence of clinically significant rest-


enosis range from 20 to 50 %. Endovascular irradiation, adminis-
tered immediately following the PTA procedure, was one of the few
interventions that dramatically reduced the incidence of restenosis
(Massulo et al., 1996; Nath and Roberts, 1996; Schopohl et al.,
1996; Tierstein et al., 1997).
Brachytherapy treatment systems fall into two major categories:

• stent-based therapy, in which an intracoronary stent which


is itself radioactive or impregnated with radioactive mate-
rial, is permanently placed at the PTCA site; and
• catheter-based therapy, in which a radioactive source is
transported through a guide catheter and temporarily posi-
tioned at the treatment site until a prescribed dose is deliv-
ered.

Typical dose fraction sizes range from 10 to 20 Gy at the luminal


surface or external elastic lamina. These distances are typically
2 to 3 mm from the catheter center for coronary arteries and as
much as 5 mm from the catheter center for peripheral arteries.
A minimal treatment time reduces both cost and medical risk to
the patient. Iridium-192 sources produce dose distributions that
offer excellent coverage of the arterial wall without excessive dose
to the endothelial layer, and the sources can be used in both cardiac
and peripheral arteries. Iridium-192 sources are backed by the
most extensive clinical and preclinical experience (Amols, 2002). It
has been demonstrated that safe and effective treatment can be
rendered using manually afterloaded 192Ir ribbons with dose rates
as high as 4,000 Gy m2 h–1 (Tierstein et al., 1997). However, the
high level of activity needed to produce adequate dose rates carries
the potential for significant personnel exposures. Limiting radia-
tion exposure is important because catheterized patients cannot be
moved to shielded vaults for treatment and because anesthesiolo-
gists and cardiologists will not leave the patient’s side. For these
reasons, conventional 192Ir-based HDR brachytherapy units, unless
available as a dedicated unit in a structurally shielded cardiac
catheterization laboratory, are impractical (Bohan, 2000).
Radiation safety issues with any of these devices generally fall
into three categories:

1. Shielding of the treatment room: Because these devices will


most likely be used in rooms with shielding designed for
diagnostic x-ray energies, an evaluation of the shielding
and the dose rates in surrounding areas shall be performed

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108 / 4. BRACHYTHERAPY

by a qualified medical physicist or qualified medical health


physicist. This evaluation should consider the number of
procedures possible without exceeding the permissible dose
limits in surrounding areas. Portable shielding may be
used to supplement the structural shielding. However, its
location and use should be specified by the qualified medi-
cal physicist or qualified medical health physicist (Balter
et al., 2000; Bohan et al., 2000; Folkerts et al., 2002).
2. Treatment of the correct anatomical location: The correct
positioning of the source relative to the area of restenosis
is critical to effective treatment. Incorrect positioning of
the source has been identified as a source of abnormal
occurrences in the reports from regulatory agencies (NRC,
2004). The QA plan shall, therefore, consider the criteria
for ensuring correct positioning and QA checks specific for
positioning shall be performed within 24 h of the adminis-
tration of treatment.
3. Failure of the source to retract: The failure of the sealed
source to retract into its housing has been identified as a
source of abnormal incidents with intravascular brachy-
therapy devices (NRC, 2004). Treatments with sealed
sources shall not be undertaken without the presence of
some type of “bailout box,” a shielded container that can
house the sealed source temporarily until a complete QC
check of the intravascular brachytherapy device can be
made. To avoid or minimize this situation, therefore, a
check of the ability of the source to retract and emerge suc-
cessfully shall be part of the QA procedures performed
immediately prior to the treatment.

The development and successful use of drug-impregnated stents


has made intravascular brachytherapy with radiation a limited
technique. There may, however, remain a smaller group of patients
(e.g., patients with stenosis in peripheral veins in limbs) for whom
radiation applications are the treatment of choice.

4.9.2 Other Experimental Applications

Various radionuclide sources have been proposed for intracavi-


tary applications. Applicator systems have been successfully devel-
oped for 241Am sources (Nath et al., 1988, Samuels et al., 1991).
Small 169Yb seeds have been used as replacements for 192Ir for tem-
porary interstitial implants (Piermattei et al., 1995). Ameri-
cium-241 has a low specific activity and high self-absorption which

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4.9 OTHER APPLICATIONS / 109

limits its use in LDR brachytherapy. Ytterbium-169 has a high spe-


cific activity (370 TBq mm–3, ~10 Ci mm–3) and it is possible that
high-intensity 169Yb sources could be used to deliver HDR intraop-
erative brachytherapy treatments in a lightly shielded operating
room, potentially broadening the clinical applications of brachy-
therapy. The use of 169Yb sources for permanent implantation is
limited by the emission of 308 keV photons which increase the radi-
ation protection hazards.
Californium-252, a radionuclide that emits fission neutrons
with an average energy of 2.14 MeV, has been intensively investi-
gated as a potential source for intracavitary treatment of gyneco-
logical neoplasms (Maruyama et al., 1997). Approximately 60 % of
the absorbed dose arising from sealed 252Cf sources is due to neu-
tron emissions. One of the rationales for the use of 252Cf is combin-
ing the advantages of conventional brachytherapy with the
presumed benefits of high-LET therapy. This advantage is bal-
anced by the increased radiation protection problems that arise
due to the necessity for the use of combined photon and neutron
shields, typically a combination of lead and a hydrogenous material
such as polyethylene, to attenuate the radiation fields. Of equal
importance is the increase in the relative biological effectiveness
for neutrons as the dose rate decreases. The use of 252Cf requires
extreme caution and special attention from the RSO for the protec-
tion of personnel.

4.9.3 Use of High Dose-Rate Units for Intraoperative


Radiation Therapy

Several institutions with large brachytherapy programs are


using HDR units in shielded operating rooms for intraoperative
radiation therapy. These programs combine surgery and radiation
oncology. The tumor is exposed and a single fraction of radiation is
delivered through the open wound. These programs are usually
only available in institutions that can commit the resources neces-
sary to build a dedicated brachytherapy operating-room suite.
The radiation safety issues in these facilities and shielding design
have been discussed in some publications (Anderson et al., 1999;
Sephton et al., 1999).

4.9.4 Balloon Applicators

Some techniques rely on balloon applicators for treatment of


malignant resection cavity margins. The standard of care for brain
tumors, particularly gliomas, has been ERT with or without the
additional implantation of 125I seeds. This technique relies on

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110 / 4. BRACHYTHERAPY

the installation of an organically-based liquid labeled with activi-


ties up to 18.5 GBq (500 mCi) of 125I into a balloon previously placed
in the surgical cavity at the time the tumor was excised (Dempsey
et al., 1998). The organic liquid and the balloon are then withdrawn
after several days of treatment. The radiation safety considerations
for this treatment are more typical of radiopharmaceutical therapy
and include contamination concerns and radioactive waste dis-
posal. Another consideration is the possibility of radioiodinated
molecules leaking out of a ruptured balloon or diffusing through
the balloon membrane into the cavity and being de-iodinated to lib-
erate radioiodide which is then transported to and concentrated in
the thyroid (DeGuzman et al., 2003; Strzelczyk and Safadi, 2004).
The use of this technique is currently limited to some larger centers
capable of the delicate surgery involved. However, if this technique
is successful in significant groups of patients, its use may be
expanded to smaller facilities.

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5. Facility Design

Radiation sources used in brachytherapy and radiopharmaceu-


tical therapy have the potential to contribute significant doses to
medical personnel and others who may spend time within or adja-
cent to rooms that contain radiation sources or patients adminis-
tered various types of radiation sources. Meaningful dose reduction
can be achieved through the use of appropriate facility design.
While the radiation sources used in both brachytherapy and radio-
pharmaceutical therapy may pose unique radiation safety issues,
facilities may be designed to protect against radiation from a vari-
ety of sources used in both modalities. This Section will discuss
separately the design of facilities used for brachytherapy and
radiopharmaceutical therapy, but facilities may be used for both
purposes when their design satisfies the safety considerations for
both types of therapy. This Section provides recommendations on
facility design that may be useful in reducing potential radiation
exposure from sources that are being prepared, are in storage, or
are being administered to or are within hospitalized patients.

5.1 General Considerations

Section 1 of NCRP Report No. 147 (NCRP, 2004a) and Section 1


of NCRP Report No. 151 (NCRP, 2005) discuss quantities and units,
shielding design goals, and effective dose. While neither of these
reports directly addresses the subject of shielding design for
brachytherapy facilities, the basic principles discussed in Section 1
of both reports will apply to brachytherapy and radiopharmaceuti-
cal therapy. The shielding design recommendations in these
reports reflect the principles outlined in NCRP Report No. 116
(NCRP, 1993b).
A “controlled area” is a limited-access area in which the occupa-
tional exposure of personnel to radiation or radioactive material is
under the supervision of an individual in charge of radiation pro-
tection. This designation implies that access, occupancy and work-
ing conditions are controlled for radiation protection purposes. In
brachytherapy facilities, such areas are usually in the immediate
areas where radiation-producing equipment or sealed sources are
used, such as treatment rooms and control consoles, or other areas
that require control of access, occupancy and working conditions for

111

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112 / 5. FACILITY DESIGN

radiation protection purposes. The workers in these areas are those


individuals who are specifically trained in the use of ionizing radi-
ation and whose radiation exposure is usually individually moni-
tored. “Uncontrolled areas” for radiation protection purposes
include all other areas in the hospital or facility and the surround-
ing environs. Trained radiation-oncology personnel, other trained
staff, as well as members of the public, frequent many areas near
controlled areas such as examination rooms or restrooms. These
areas should be treated as uncontrolled for purposes of shielding
design.
There are different shielding design goals for controlled and
uncontrolled areas. Shielding design goals are practical values for
a single brachytherapy or nuclear-medicine source or sets of
sources that are evaluated at reference points beyond a protective
barrier. The shielding design goals ensure that the respective
annual values for effective dose recommended in NCRP Report
No. 147 and Report No. 151 (2004a; 2005) for controlled and
uncontrolled areas are not exceeded. Shielding design goals are
expressed most often as weekly values because the workload for
treatment facilities and the length of stay for radiopharmaceutical
therapy has traditionally utilized a weekly format.

5.1.1 Controlled Areas


NCRP recommends an annual effective dose limit for occupa-
tional personnel of 50 mSv y–1 with the cumulative effective dose
limit not to exceed the product of 10 mSv and the worker’s age in
years (exclusive of medical exposure received as part of the
worker’s health care and natural background radiation) (NCRP,
1993b). NCRP also recommends that new and modified medi-
cal-radiation facilities should be designed to control annual occupa-
tional doses to individuals (i.e., in controlled areas) to a fraction of
the 10 mSv y–1 value implied by the cumulative effective dose limit
as discussed in NCRP Report No. 116 (NCRP, 1993b) and Report
No. 147 (NCRP, 2004a). Another design consideration is that a
pregnant radiation worker should not be exposed to levels that
result in greater than the monthly equivalent-dose limit of 0.5 mSv
to the worker’s embryo or fetus (NCRP, 1993b). To achieve these
recommendations, NCRP Report No. 147 and No. 151 (NCRP,
2004a; 2005) recommend an annual effective dose value of
5 mSv y–1 (one-half of the 10 mSv y–1 value), and a weekly shielding
design goal of 0.1 mSv dose equivalent (an annual value of 5 mSv
dose equivalent). For controlled areas this shielding design goal
would allow pregnant radiation workers continued access to their
work areas.

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5.1 GENERAL CONSIDERATIONS / 113

Recommendation for Controlled Areas:


Shielding design goal (in dose equivalent):
0.1 mSv week (equivalent to 5 mSv y–1).

5.1.2 Uncontrolled Areas

Uncontrolled areas are occupied by individuals such as patients,


visitors to the facility (e.g., delivery service, representatives, and
consultants) and employees who do not work routinely with or
around radiation sources. Areas adjacent to, but not part of the
brachytherapy or nuclear-medicine facility may also be designated
as uncontrolled areas. Based on recommendations in NCRP Report
No. 116 (NCRP, 1993b), recommendations for the annual limit of
effective dose to a member of the public, shielding designs shall
limit exposure of all individuals in uncontrolled areas to an effec-
tive dose that does not exceed 1 mSv y–1. The design and use of new
or modified medical-radiation facilities should be adequate to con-
trol the effective dose to members of the public (i.e., in uncontrolled
areas) to 1 mSv y–1 (NCRP, 2004a; 2004b). This recommendation
can be achieved with a weekly shielding design goal of 0.02 mSv
dose equivalent (an annual value of 1 mSv dose equivalent).

Recommendation for Uncontrolled Areas:


Shielding design goal (in dose equivalent):
0.02 mSv week (equivalent to 1 mSv y–1).

A qualified expert should participate in the planning, design


and acceptance testing of new or modified brachytherapy and
radiopharmaceutical-therapy facilities to ensure that appropriate
consideration is given to site selection, facility layout, shielding,
ventilation, space for preparation and storage of radiation sources,
and physical safeguards. Competent review during design and con-
struction will ensure that the facility design will be adequate to
permit operation within established safety standards and maintain
radiation exposure at levels that are ALARA.

5.1.3 Designation of Occupational Radiation Employees

The vast majority of patients who receive temporary implant


therapy and some patients who receive permanent implants or
radiopharmaceutical therapy need to be confined to a controlled
area of the hospital that is staffed by appropriately trained care-
givers. These personnel should be considered radiation workers if:

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114 / 5. FACILITY DESIGN

• they work directly with radiation sources; or


• they have a reasonable possibility of receiving an annual
effective dose exceeding 1 mSv; or
• the potential for a patient incident is non-negligible and
failure to bring such an incident under control could result
in effective doses >1 mSv to some individual.

In assessing the applicability of these criteria, both the fre-


quency of procedures in question and the intensity of medical care
required (basically, the occupancy factor for the nursing staff)
should be considered. In general, it is not always necessary to room
patients in a controlled area when they contain permanent
implants of low-energy photon sources such as 103Pd or 125I; beta-
emitting radiopharmaceuticals, such as 32P; or smaller amounts of
gamma-emitting radiopharmaceuticals for the treatment of benign
conditions, such as the use of 131I for treatment of hyperthyroidism.
Some patients with temporary implants that contain high activity
low-energy sources (e.g., episcleral plaque therapy for intra-ocular
malignancies) may not need to be confined to a controlled area. The
criteria above may not be met when significant numbers of patients
are treated with interstitial and intracavitary implants using 137Cs,
192Ir, high specific activity 125I, or very large doses of gamma-emit-

ting radiopharmaceuticals. However, the situation for each patient


shall be evaluated by measurement as described in Section 5.1.4.

5.1.4 Consideration for Patient Areas

Placing brachytherapy patients or radiopharmaceutical ther-


apy patients in existing, unshielded hospital rooms may expose
persons in adjacent areas to an effective dose that >1 mSv during
the treatment period. There may also be regulatory requirements
for limiting the dose in unrestricted areas that need be met. Sev-
eral actions can be taken to minimize radiation exposure to persons
in adjacent areas, such as evacuation of adjacent patient rooms and
use of portable shielding. Radiation measurements shall be made
after each intervention to confirm that the potential dose is within
regulatory limits. Worst case scenarios may be documented and
used to demonstrate the conditions under which these limits are
satisfied to avoid the necessity of measuring exposure rates in adja-
cent areas (especially adjacent, occupied patient rooms) during
every treatment. The RSO shall be consulted to determine whether
adjacent rooms should be vacated or whether use of portable
shielding or other actions could reduce radiation exposures in adja-
cent areas to acceptable levels.

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5.2 BRACHYTHERAPY TREATMENT / 115

If the hospital has designated certain rooms for brachytherapy


patients, it may be advantageous to use the same rooms for radio-
iodine inpatients, particularly if these rooms have been shielded.
Medical personnel for these rooms shall be trained in radiation
safety procedures and shall be familiar with limitations associated
with visitors and ancillary personnel. Facilities that treat a large
number of patients may wish to consider installation of structural
shielding in designated room(s). The ideal time to install shielding
is during new construction. However, shielding can be added at any
time to existing rooms in facilities that are capable of supporting
the additional weight. Permanent shielding may consist of poured
concrete, core filled concrete block, steel plate, or lead sheet. A
detailed discussion of the advantages and disadvantages of shield-
ing materials in common use can be found in Section 4.3 of NCRP
Report No. 151 (NCRP, 2005). Table B.3 of this Report lists the
properties of various shielding materials in common use. Section 4
of this Report also provides shielding details for joints and junc-
tions between barriers and shielding details for duct penetrations
that will apply to all facilities. Care shall be taken to ensure that
voids are adequately shielded.

5.2 Brachytherapy Treatment

Radiation-oncology personnel may be exposed to a variety of


radiation sources. Radionuclide sources used in brachytherapy are
the most significant source of occupational radiation exposure to
radiation-oncology personnel. Occupational and public exposure
may occur during receipt, transport and preparation of sources,
loading and unloading sources in brachytherapy applicators, and
care of patients during the course of treatment.
A brachytherapy facility consists of all dedicated and shared
physical and technological resources that are required to plan and
deliver sealed-source brachytherapy treatments. A brachytherapy
facility may include:

• a treatment planning area;


• an operating room or procedure room in which applicators
or sources can be placed in the patient;
• a radiographic imaging system for documenting the location
and geometry of the sources and the applicator or catheters;
• a treatment room; and
• a source preparation and storage area for use with LDR
implants.

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116 / 5. FACILITY DESIGN

Facilities for treatment of brachytherapy patients fall into two


very different groups: conventional LDR inpatient-based therapy
and outpatient-based fractionated HDR brachytherapy.
Facility design in both cases is dictated by similar consider-
ations:

• medical and physical well-being of the patient;


• protection of the staff, visitors and other members of the
public from actual and potential radiation hazards; and
• geographic and functional integration of treatment delivery
with the applicator-insertion, implant-imaging, treatment-
planning, and treatment-evaluation activities.

Because of the very large difference in source strength needed


for LDR and HDR treatment modalities, the facilities needed, the
temporal distribution of treatment, and the magnitude of radiation
hazards to be managed are quite different. Each of the various
types of brachytherapy is discussed in the following sections.

5.2.1 Treatment-Area Design

Selection criteria and design endpoints for the treatment-deliv-


ery area include:

• proximity to specialized nursing and medical inpatient ser-


vices needed to provide good quality medical care of the
patient;
• functional adequacy including floor space needed for shields
and any remote afterloading equipment;
• proximity to the operating rooms, imaging facility, and
source preparation area;
• proximity to and occupancy of surrounding uncontrolled
areas;
• structural integrity of the building needed to support the
weight of required structural or portable shielding;
• well-defined areas to house the patient, entry to which by
the general public and nonoccupationally-exposed hospital
workers can be controlled by the nursing staff. Except for
those patients permanently implanted with low-energy pho-
ton sources such as 103Pd or 125I, implanted patients shall be
housed in private rooms. The entire room occupied by an
implanted patient shall be considered a controlled area.

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5.2 BRACHYTHERAPY TREATMENT / 117

• protection of members of the public, including nonradioac-


tive patients or nonoccupationally-exposed workers, who
frequent the uncontrolled areas surrounding the facility;
and
• protection of occupationally-exposed personnel (e.g., nurses,
radiation therapists, oncology staff) and other caregivers,
who have been designated as radiation workers.

These criteria may be met cost effectively by grouping treat-


ment rooms together in one or two limited areas rather than using
individual patient treatment suites throughout the hospital. This
approach limits the number of persons who must receive annual
training and develops nursing expertise in managing both the
safety and clinical aspects of brachytherapy by maximizing proce-
dure frequency. Some hospitals may not wish to admit all implant
and radiopharmaceutical therapy patients to a single area of the
hospital because such organization may not be consistent with
the goal of providing good quality medical care to implanted
patients. For example, patients with implants of the oral cavity,
tongue and neck may need specialized wound care, and the need to
respond quickly to clinical problems may demand nursing skills
typically not found in other nursing units. It may be possible to par-
tially address this issue by providing additional training to nurses
on a grouped unit or by rotating specially trained nurses through
the area that contains the treatment rooms. Individual brachyther-
apy treatment rooms may be grouped together to the extent that
the quality of patient medical care is not compromised. For an insti-
tution with a large brachytherapy program where such groupings
are not feasible, the development of two or three specialized facili-
ties may be considered in high-volume locations (e.g., gynecologic
oncology, otorhinolaryngology, and thoracic surgery).
Implant rooms should be selected to minimize both the uncon-
trolled personnel traffic in and out of the area and the shielding
needed to protect surrounding uncontrolled areas. Placing rooms in
the corner of a building often avoids the need to shield all walls
in the designated room, especially when treatment rooms are not
located at street level. Optimally, a dedicated suite of adjacent
rooms on both sides of a blind-end corridor can be designated for
brachytherapy and the area defined by means of a properly posted
door. The entire posted area can be designated as a controlled area.
Use of single isolated rooms requires that the hallway and the sur-
rounding adjacent rooms be treated as uncontrolled areas unless
they are vacated or occupancy is controlled during the treatment.

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118 / 5. FACILITY DESIGN

The need for structural or portable shielding shall be carefully


assessed by a qualified expert before placing a brachytherapy or
radiopharmaceutical treatment room into service. Appendix D
summarizes the considerations for shielding of HDR brachyther-
apy facilities as well as general considerations in shielding design.
Shielding calculations both for controlled and uncontrolled areas
shall take into account maximal expected workload and occupancy
factors. The thickness of a typical hospital floor is from 10 to 15 cm
of concrete, a thickness that may limit the workload for certain
types of applications (e.g., the use of 137Cs for intracavitary
implants). New construction may use sheetrock for interior walls
but sheetrock walls provide negligible protection for energetic pho-
ton emitters. Older buildings constructed with cinder block or solid
concrete block may provide significant radiation shielding. These
assessments should be made by a qualified expert.
For protection of adjacent rooms, portable lead shields may be
used, although it must be recognized that such shields are rarely
large enough to confer protection to the entire room. Inpatient beds
in adjacent rooms should be assigned occupancy factors of 100 %
(T = 1). Table B.1 of NCRP Report No. 151 (NCRP, 2005) provides
suggested occupancy factors for use as a guide in shielding design.
The occupancy factor (T) for an area is the average fraction of time
that the maximally exposed individual is present. This Report is
intended to support shielding design for megavoltage radiations. In
these facilities, the treatment beam cycles on and off as patients
are treated. However, in brachytherapy and radiopharmaceutical
therapy treatment, the source of radiation is continuously present
throughout the course of the treatment. Consequently, there will be
no application of a “use factor,” or fraction of “beam-on” time on a
shielded barrier, that can be applied in the design of brachytherapy
or radiopharmaceutical therapy facilities.
When using lower occupancy factors, care should be taken that
the integrated dose within 1 h falls within the applicable regula-
tory limit for unrestricted areas. Following installation of struc-
tural shielding or placement of portable shielding, a radiation
survey of the surrounding areas using an appropriately sensitive,
calibrated ion-chamber survey meter shall be made to confirm the
intent of the shielding calculations. If the survey reveals that
the shielding is not adequate to satisfy the applicable exposure lim-
its, either the workload or occupancy of the surrounding areas shall
be limited appropriately. Alternatively the shielding could be aug-
mented if feasible.
Other equipment needed in treatment facilities include portable
shields for protection of staff and lead storage containers for use

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5.2 BRACHYTHERAPY TREATMENT / 119

in patient rooms. All rooms occupied by implanted patients or


containing supplies of radioactive sources should be posted as con-
trolled or restricted areas. Intercom systems should be used to
reduce the need for entry of patient care and ancillary personnel
into the treatment room.

5.2.2 Low Dose-Rate Conventional Remote Afterloading Systems

Shielding requirements for uncontrolled areas surrounding the


treatment area are unchanged by the use of LDR remote afterload-
ing because the shielding design would be the same as that for
nonafterloading systems. The major benefit of LDR remote after-
loading is reduction of exposure to nursing and other inpatient per-
sonnel who attend the patient. Operationally, the use of LDR
remote afterloading avoids the need for portable shielding used
solely to protect occupationally-exposed personnel and visitors
entering the treatment room. Shielding in the treatment room will
not be necessary because anyone entering the treatment room
will trigger the source interlocks causing the sources to retract.
Treatment rooms used for LDR remote afterloaded brachyther-
apy should satisfy all relevant requirements for manually after-
loaded brachytherapy. In addition:

• additional floor space for positioning the treatment device


and any specialized utilities such as dedicated compressed
air and power sources may need to be provided;
• door interlock that causes all sources to be retracted when-
ever the door is opened shall be provided. The interlock
mechanism shall not cause sources to return to treatment
positions by closing the door without initiating a treat-
ment resumption command from the control panel. If an
operational door interlock system cannot be provided, nurs-
ing and medical personnel shall be instructed to practice
manual afterloading patient procedures, or the room should
be equipped with an alternative system for verifying source
retraction (e.g., an area monitor);
• treatment rooms shall be equipped with an independent
area monitor that clearly indicates to staff entering the
room whether all sources have been retracted upon inter-
rupting treatment; and
• remote afterloaders shall be equipped with visual or audible
signals that clearly indicate the presence of any error condi-
tion that jeopardizes treatment accuracy or staff safety.
These signals shall be monitored continuously during
patient treatment.

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120 / 5. FACILITY DESIGN

5.2.3 Requirements for Source Preparation and Storage Room

The source preparation room shall include:

• an area where all LDR sealed sources can be safely stored in


an orderly fashion;
• space and facilities for receiving and returning sources, cali-
bration of sources, assessment of homogeneity, inventory of
sources, and QC tests;
• space and equipment for source preparation for specific
patient treatments;
• a work area in or near the preparation room where records
can be prepared and stored and not be subject to radioactive
contamination;
• space for QA and treatment aids; and
• space, if necessary, for storage of short-lived sources or tem-
porary storage of unused long-lived sources.

The source-preparation room should be located near the LDR


treatment rooms and should not be shared with other functions.
The room shall be posted with radiation warning signs and
equipped with a lock to secure the area from unauthorized entry. A
latch should automatically lock the door and require a mechanical
or electronic key to open the door. A structurally adequate work-
bench sufficient for supporting the shielding required for personnel
and the source safe should be in the room. Space for calibra-
tion-source homogeneity checks and shielded transport containers
shall be provided within the source preparation room. Personnel
shielding such as a leaded “L-block” shall be provided. This shield-
ing shall include a leaded window of sufficient thickness that
allows the operator to manipulate and visualize LDR brachyther-
apy sources without significant whole-body or eye exposure. The
adequacy of this local shielding system shall be verified by a qual-
ified expert before initiating use. Additional space or safes may be
needed if unused sources are to be stored. Once the local shielding
is in place, an assessment of the protection afforded to surrounding
areas shall also be performed prior to initiating use. Changes or
additions to the local shielding may be necessary based on the
results of this assessment. The room should be carefully laid out to
ensure that occupational doses are maintained ALARA. Local
shielding such as interlocking lead blocks to reduce exposure rates
during source preparation, record keeping and other work func-
tions shall be used throughout the working areas. Occupancy of the
area should be limited to persons immediately involved in source

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5.2 BRACHYTHERAPY TREATMENT / 121

preparation. The preparation of radioactive sources (e.g., selection


and trimming of 192Ir ribbons or loading of intracavitary source
inserts) should be performed in the source preparation area.

5.2.4 Low Dose-Rate Procedure Rooms and


Treatment-Planning/Imaging Equipment

Applicator insertion can be performed in any operating room


that supports the surgical procedures needed to evaluate the
patient's condition and expose the implant site. For many types of
procedures, an imaging system (e.g., a radiographic or CT unit) for
intraoperative examination of source placement and geometry is
highly recommended. This allows implants with suboptimal or poor
geometry to be rapidly identified and corrections made while the
patient is still in the operating room. Shielding for these systems
should meet the shielding design goals for medical x-ray imaging
facilities specified in NCRP Report No. 147 (NCRP, 2004a).

5.2.5 Requirements for High Dose-Rate Brachytherapy Facilities

High dose-rate (HDR) brachytherapy facilities are usually


located within the radiation-oncology department and treatments
are staffed by radiation-oncology personnel (therapists, dosime-
trists and physicists in addition to the radiation oncologist).
The size of the facility and accessories needed depend on whether
both imaging and applicator insertion will be performed in the
treatment room (Glasgow and Corrigan, 1995b). Facilities to be
designed range from using space within an existing ERT treatment
room in which an HDR unit is placed to an integrated HDR operat-
ing room in which applicator insertion, imaging and treatment are
executed without moving the patient. Treatment planning may be
more complex than that for LDR brachytherapy, ranging from 15 to
30 min for manual calculation for planning of a simple line source,
to 1.5 h for complex optimization of an intracavitary insertion, to
several hours for a large interstitial implant. Patient treatment
loads are typically limited to three to eight HDR procedures per day
on a single machine, depending on the complexity of treatment
planning required (see Appendix D for a complete discussion of
shielding of HDR brachytherapy facilities).
An HDR brachytherapy facility requires a:

• operating or procedure room;


• radiographic imaging system;
• dedicated treatment room; and
• treatment planning area.

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The relative proximity of these facilities can significantly influence


procedure flow and efficiency. For example, if the treatment plan-
ning area is near the HDR control console, the physicist can per-
form or supervise treatment planning while being available to
respond to treatment-machine malfunctions.
There are four major options for a dedicated HDR facility:

• sharing a treatment vault between an HDR remote after-


loader and a linear accelerator or teletherapy machine,
using existing operating rooms and imaging equipment. If
the external-beam equipment is used heavily, the HDR
treatment times will be limited and will require careful
scheduling among the three resources: treatment room,
operating or procedure room, and imaging facility;
• dedicated vault for the HDR unit using existing operating
rooms and simulator. A larger patient load, typically from
three to five procedures per day, can be sustained. However,
the patient must be transported twice (operating or proce-
dure room to simulator and simulator to treatment room), a
requirement that reduces efficiency, hinders immobilization
of the applicator system, and for some gynecological applica-
tor systems, may result in a higher incidence of organ perfo-
ration. Also, a holding area for patients is required;
• dedicated vault in which both applicator insertion and
treatment are carried out while imaging is performed else-
where. If no cervical dilations or other invasive procedures
are to be performed, only an appropriate procedure table
may be required. However, if regional or general anesthesia
is required, along with control of sterility, then a significant
investment, including scrub and recovery areas and anes-
thesia stations, is needed. Other medical staff (e.g., gyneco-
logic oncologist and anesthesiologist) must be committed to
supplying medical services outside their usual venue. A sig-
nificant patient load, from five to eight procedures per day,
can be accommodated, depending on the complexity of treat-
ment planning; and
• integrated brachytherapy suite. This option carries the
approaches above to their logical conclusion by incorporating
a dedicated HDR system into an operating/treatment room.
No transport of the patient between applicator insertion
and treatment is required affording the ultimate in applica-
tor-system immobilization, treatment-delivery efficiency,
patient comfort and protection of the patient from trauma.

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The optimal choice among various alternatives depends prima-


rily on the anticipated patient load. The more expensive options
should be reserved for programs anticipating a load of at least 500
procedures annually or more than three procedures on each day of
use. Other considerations are the clinical importance attached to
good immobilization and the complexity of treatment planning con-
sidered necessary. As an example, if extensive optimization of
source positioning and dwell-times is required, the factor limiting
patient load may become the time required for treatment planning
and dose calculation rather than the design of the facility. Close
cooperation among the radiation oncologist, the physicist, and
other involved medical personnel is essential to identify the design
criteria and to design a facility that meets the medical facility’s
needs for the least capital investment. No single design serves
all needs, because the design process is driven by so many facility-
specific logistical and clinical constraints.
The essential safety features of an HDR treatment room are:

• properly shielded area: As discussed in Section 5.1, for adja-


cent uncontrolled areas, shielding shall be designed to limit
the annual effective dose to members of the public, includ-
ing nonradioactive patients, to 1 mSv as a result of brachy-
therapy procedures. For surrounding controlled areas,
shielding shall be designed to control occupational expo-
sures to the annual dose value specified by an institution’s
ALARA program. Portable shields shall not be used for
this purpose. The adequacy of the proposed or existing
shielding design shall be reviewed by a qualified expert.
Before implementing an HDR treatment program or other-
wise accumulating significant integrated dose, the dose
rates in surrounding areas shall be measured using a prop-
erly calibrated ion-chamber survey meter [see Section 6 of
NCRP Report No. 151 (NCRP, 2005) for a discussion of sur-
veys]. The survey results shall be reviewed by a qualified
expert. If the results indicate that the applicable effective
dose values could be exceeded, the facility shall limit the
patient treatment workload, augment the shielding, or
appropriately limit occupancy in surrounding areas to pre-
vent the applicable values from being exceeded.
• secure area: Considerations regarding security of these
areas have become an increasing cause of concern following
the events of September 11, 2001. The potential for sources
used in HDR units to be stolen and placed in so-called “dirty
bombs” has caused many facilities to substantially increase

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124 / 5. FACILITY DESIGN

the level of security for these areas. When not supervised by


trained personnel, the HDR facility or treatment facility
shall be secured to prevent inadvertent exposure of individ-
uals and tampering with the HDR unit itself. The security
plan including the locks on such a room shall be reviewed
with a security expert. Keys for the facility should be sepa-
rate from master keys for other areas in the facility and the
use of card access, fingerprint scanning, or other security
measures should be part of the overall security plan. Access
to the units, including the provision of keys, should be under
the immediate control of the physics or radiation-oncology
staff and the number of persons present at the units should
be limited and under the immediate supervision of the radi-
ation-oncology staff. Access to the operator's key for the con-
trol console should be controlled by the radiation-oncology
staff and restricted to a list of specific individuals. In addi-
tion to access controls, consideration should also be given to
fastening down the units themselves to prevent relocation
or theft. Plans to implement these measures should be
reviewed with a security expert.
• engineered/administrative controls such as:
- a door interlock system that causes the source to retract
upon opening the door;
- an independent area monitor visible at the entrance;
- appropriate radiation warning signs;
- “beam-on” light that is activated whenever the source is
in the exposed position;
- systems for maintaining visual and aural contact with
the patient during treatment (e.g., television monitoring
systems and two-way intercom systems);
- a copy of the operator's manual, including all relevant
procedures for operation of the device, written emer-
gency procedures, and explanations of all error codes,
placed near the operator's console;
- fault detection logic capable of detecting source retrac-
tion failure, separation of the source from its cable, and
unscheduled displacement of the source from its pro-
grammed treatment position or position in the shielded
safe. Such fault detection logic should alert users to the
problem and prevent further treatment. Error-detection
and recovery systems located on the HDR afterloader
shall be thoroughly tested before implementing a clinical
treatment program and should be tested at appropriate
intervals thereafter;

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5.2 BRACHYTHERAPY TREATMENT / 125

- emergency procedures shall be developed for quickly


detecting HDR source retraction failures and bringing
the source under control. These procedures shall include
use of a radiation survey meter to confirm source
containment, use of a cable cutter and tools to safely
manipulate the source, and emergency removal of the
applicators if needed. Equipment needed to implement
these procedures, such as a shielded storage container,
forceps, cable cutters, etc., shall be present whenever the
device is used; and
- a calibrated survey meter, capable of detecting source
exposure in the presence of HDRs. The survey meter
shall be available whenever the HDR remote afterloader
is used).

In calculating required shielding, workloads should be esti-


mated conservatively (i.e., in the safe direction) and should include
source exposures anticipated for QA, source calibration, and other
measurements. A moderately large workload might be estimated at
100 patients per year with an average between three to five treat-
ment fractions per patient. It is usual to assume that the workload
will be evenly distributed throughout the year. Therefore, it is rea-
sonable to design a barrier to meet the weekly shielding design
goals discussed in Section 5.1. Treatment rooms are often con-
structed below ground level as the most economic strategy for
reducing shielding costs. For rooms below ground (below grade),
the costs of excavation, when necessary, sealing against water and
provision for access need to be considered in light of the overall
cost.
When HDR units are placed within existing linear accelerator
vaults, it can usually be safely assumed that no additional shield-
ing is necessary. However, placing the unit in such a room will
mean that for a portion of the treatment week, patients cannot be
treated on the linear accelerator. For a dedicated HDR treatment
room, 40 to 60 cm of concrete or from 5 to 7 cm of lead would typi-
cally be required to adequately shield uncontrolled areas, depend-
ing on the location of the source relative to the areas under
consideration and the occupancy of the adjacent areas. Every wall,
the ceiling, and the floor in the HDR treatment room shall serve as
a primary barrier. Although primary-beam teletherapy shielding is
usually more than adequate, existing teletherapy barriers, includ-
ing the door to the facility, designed only to protect against scat-
tered and leakage radiation may not be adequate for HDR
brachytherapy. If the HDR source location is not fixed to a single

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126 / 5. FACILITY DESIGN

location in the room, the influence of source position on shield-


ing efficacy shall be evaluated by a qualified expert. If the shielding
design restricts the source to a designated location within the
room, the location shall be permanently marked or otherwise fixed
on the floor.
As noted above, following installation of the HDR remote after-
loader, the adequacy of all shielding barriers shall be confirmed by
a qualified expert performing an appropriate facility survey. Sec-
tions 6.1, 6.2 and 6.3 of NCRP Report No. 151 (NCRP, 2005) can be
applied to HDR facilities. Thereafter, surveys should be performed
at appropriate intervals or whenever changes in surrounding space
utilization, HDR workload, positioning of the remote afterloader, or
modifications to the structural shielding call into question the ade-
quacy of the existing survey.

5.2.6 Additional Requirements for “Pulsed” Dose-Rate


Brachytherapy Facilities

Pulsed dose-rate (PDR) units have been suggested as substi-


tutes for LDR applications. In principle, PDR brachytherapy
requires no additional shielding above that required for the corre-
sponding continuous LDR implant, because the average hourly
absorbed-dose rate, in Gy m2 h–1, and total treatment absorbed
dose, in Gy m2, are unchanged. Shielding requirements could
decrease if a PDR 192Ir source is used to replace conventional
sources of 137Cs. Use of large pulse widths for several days may
make it possible to exceed the shielding design goal of 1 mSv y–1 for
uncontrolled areas. Before implementing a PDR brachytherapy
treatment, the user shall evaluate the average hourly and weekly
exposures to determine that the proposed dwell-time per pulse and
cumulative dwell-time will not result in exceeding the appropriate
shielding design goals for controlled and uncontrolled areas. Spe-
cific procedures for implementing this requirement have been pub-
lished (Williamson et al., 1995).

5.3 Facilities for Unsealed Sources

Nuclear-medicine personnel receive occupational exposure from


numerous radionuclide sources, including those used in therapeu-
tic applications. Commonly used radionuclides in therapeutic
nuclear medicine include beta emitters (e.g., 90Y and 32P) and
photon sources (e.g., 131I) (Tables 3.1, 3.2, and 3.3). While energetic
beta emitters may contribute to significant hand doses during han-
dling, such sources do not contribute significantly to whole-body

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5.3 FACILITIES FOR UNSEALED SOURCES / 127

radiation exposure. On the other hand, energetic, penetrating


gamma radiation may contribute significant whole-body doses to
personnel. In terms of facility design, beta emitters pose a negligi-
ble external exposure hazard. Exposure from photon emitters will
need to be reduced by adequate facility design.

5.3.1 Radiopharmaceutical Dispensing Laboratory

It is unlikely that a laboratory will be designed only for thera-


peutic purposes and the design of the laboratory shall consider the
diagnostic and therapeutic applications in use in the facility. In
general, if the dispensing laboratory or nuclear pharmacy has been
designed for the use of radioiodine, in particular 131I, it will gener-
ally provide adequate protection for use of other radiopharmaceu-
ticals. However, the overall laboratory design shall be reviewed by
a qualified expert. A fume hood shall be equipped with a char-
coal-filtered exhaust to capture any radioiodine that is vaporized
during the dispensing procedure. The fume hood shall be certified
and have an appropriate flow velocity (typically from ~100 to
150 linear ft min–1). Concentration of radioiodine in exhaust gas
shall be reviewed at least annually to verify that concentrations
released to the atmosphere are below any applicable regulatory
limits. In addition to the shielding provided by the original ship-
ping container, additional local shielding may be necessary to pro-
tect personnel who dispense therapeutic radiopharmaceuticals as
well as personnel in adjacent rooms. Exposure-rate measurements
shall be conducted in adjacent areas to confirm that radiation doses
are ALARA (NCRP, 1998). Personnel who work in the dispensing
laboratory shall use adequate physical safeguards to maintain
radiation exposures to themselves and others ALARA. Physical
safeguards include all physical devices used to restrict access of
staff and other individuals to radiation sources or to reduce radia-
tion levels as described in NCRP Report No. 71 (NCRP, 1983). Such
physical safeguards may include: shielding (generally lead), long
tongs or forceps for handling radioactive sources, “warning”
signage and postings, locks, and audible and visual alarms inte-
grated into radiation monitoring equipment. Protective devices
used to minimize uptake of radionuclides include: protective cloth-
ing such as laboratory coats, protective eyewear, disposable gloves,
sleeve protectors, shoe covers, aprons, plastic-backed absorbent
pads, water-tight containers (e.g., spill-proof vials with crimped
rubber septa), glove boxes, high exchange-rate room exhaust
systems, fume hoods equipped with trapping filters, and respira-
tory protection devices. Radioactively contaminated disposable or

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128 / 5. FACILITY DESIGN

nondisposable items shall be treated appropriately and held for


decay in storage in a properly designed area or disposed of as radio-
active waste.
Security of a radiopharmacy, and the radioactive materials con-
tained in it shall be reviewed by a security expert. Access to the
radiopharmacy should be restricted to nuclear-medicine staff dis-
pensing the radiopharmaceuticals. Delivery of stock materials from
a radiopharmacy off-site should require that the materials received
be placed in a locked, secure area until the radiopharmacy staff
moves the materials to their final destinations. Coded access to
these areas and other procedures to limit access shall be in place.
Receipt of shipments off-hours may require specific training for
receiving or security personnel by the facility radiation safety staff.

5.3.2 Storage of Low-Level Radioactive Waste

The types of wastes generated by the therapeutic applications of


radioactive materials will generally fall into four categories:

• sealed sources whose activities have decayed below the lev-


els required for clinical use;
• materials contaminated during preparation of therapeutic
radiopharmaceuticals;
• patient wastes (excluding patient excreta); and
• medical wastes containing small amounts of radioactive
materials.

Sealed sources will not present problems of contamination, but will


require storage for long periods (i.e., periods up to or exceeding 2 y)
depending on their half-lives. The amount of storage space needed
will vary depending on the size of the overall program including
unsealed sources. The sources may need to be stored in shielded
containers to reduce the exposure rates in adjacent areas. A gen-
eral discussion of management techniques for low-level radioactive
waste is beyond the scope of this Report, but this topic is discussed
in NCRP Report No. 143 (NCRP, 2003). Volume reduction of low-
level radioactive wastes should be practiced whenever possible.
Such reduction is not only based on economics and ALARA princi-
ples but on the necessity of good stewardship of the limited
resources available.
Patient wastes generated from radiopharmaceutical therapies
may need to be stored for decay for periods from one week to several
months depending on the activity used and the identity of the radi-
onuclides used. Provision for the storage of patient wastes should

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5.3 FACILITIES FOR UNSEALED SOURCES / 129

include consideration of the overall volumes involved and the pos-


sibility of structural shielding being necessary. Designers of a
waste handling area may also need to consider the infection control
issues associated with contaminated medical wastes including
syringes, needles, intravenous tubing, and blood. Such wastes may
require engineered spaces and refrigeration in certain situations.
Institutions with large radiopharmaceutical therapy programs
can accumulate substantial volumes of contaminated linen and
waste that when grouped in one location may represent a large
diffuse source of radiation. Centralized waste depots may require
the use of portable or structural shielding which should be specified
by a qualified expert. To minimize the storage of some spent sealed
sources (e.g., 125I seeds or 192Ir seeds in ribbons), it may be possible
to return these sources to the vendor. When not feasible, localized
portable shielding such as lead bricks may provide sufficient
shielding. However, because these sources may have relatively long
half-lives such storage may be necessary for several years. Sources
should be stored until the radionuclides have decayed by 10 half-
lives or until a survey conducted by radiation safety staff indicates
that only background levels of activity are present.

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6. Changes in Medical
Status of the Radioactive
Patient

The decision to treat a patient with brachytherapy or radiophar-


maceutical therapy shall involve consideration of the ability of the
patient to comply with radiation precautions and the patient’s
overall medical condition. In the event of deterioration in the
patient’s medical condition, frequent or continual monitoring of
the patient may be necessary. Examples of such cases include sep-
tic shock, pulmonary edema, and myocardial infarction. If a
patient’s condition deteriorates significantly, the patient may need
to be transferred to intensive, special care, or cardiac care units
where special monitoring is available. Typically, patients in these
units are in close proximity to each other with little or no shielding
available, and may present a radiation hazard to other patients or
to patient-care personnel. The radiation oncologist or nuclear-
medicine physician and the RSO shall be notified of the transfer to
a special unit as soon as possible, preferably before the transfer
takes place. If a patient is being treated with a temporary implant,
the radiation oncologist should consider whether the sources
should be removed. The RSO or designee shall determine whether
portable shielding is needed to reduce doses to other patients or to
patient-care personnel and whether personal monitoring is neces-
sary. The RSO or designee shall provide information on radiation
precautions necessary to keep radiation exposures to patient-care
personnel ALARA.

6.1 Cardiac or Respiratory Arrest


Lifesaving efforts shall take precedence over consideration of
radiation exposures received by medical personnel. The medical
emergency shall be declared as soon as the life-threatening event
is discovered, and lifesaving efforts shall begin immediately. Per-
sonnel in the room should be limited to those persons necessary for
medical management. The RSO shall be notified as soon as is
feasible. If the patient is being treated with a temporary implant,
the radiation oncologist should be notified immediately to deter-
mine whether the sources should be removed. Patients treated with

130

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6.2 MENTAL STATUS OF THE PATIENT / 131

permanent seed implants generally do not present a radiation haz-


ard to medical personnel responding to a code.
In the case of a patient treated with a therapeutic amount of a
liquid radiopharmaceutical <48 h prior to an emergency, it should
be assumed that body fluid samples contain activity. The dilution
of the concentration of activity by the volume of circulating blood
will usually be large enough so that the activity in any single sam-
ple is below exempt amounts (i.e., amounts of radioactive material
so low that the NRC exempts them from regulatory control). Life-
saving efforts may result in contamination of the hands or gloves
and clothing of medical personnel performing this procedure. These
personnel should not be allowed to leave the area of the medical
emergency until radiation safety personnel have decontaminated
the persons involved. Decontamination of the location where the
medical emergency has taken place may also be necessary, and
should be undertaken by radiation safety staff once the medical
emergency has been resolved.

6.2 Mental Status of the Patient

Evaluation of the ability of a patient to follow radiation safety


instructions shall be an integral element in the overall treatment
plan. If the patient is disoriented, uncooperative or violent, the
patient may attempt to remove the sources or applicator or attempt
to leave the facility. The attending physician should consider
whether sedation or restraint is justified in such cases. The cooper-
ation of patient-care personnel is essential, and all persons caring
for the patient should be involved in discussion of the treatment
plan. Patients with a history of substance abuse may, under the
stress of treatment, experience a psychotic episode. These patients
should be monitored carefully to anticipate any problems.

6.3 Emergency Surgery

If a patient containing therapeutic amounts of radionuclides


requires emergency surgery, consideration of radiation exposure
should not deter the surgery from proceeding. Preparation for the
surgery should include consultation with the attending radiation
oncologist or nuclear-medicine physician and the RSO. If this is not
possible and the situation is life-threatening, the surgery should
proceed and necessary information should be conveyed to the sur-
gical team as soon as the attending radiation oncologist or nuclear-
medicine physician and the RSO are available. It is not likely that
an individual surgeon will perform an appreciable number of

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132 / 6. CHANGES IN MEDICAL STATUS OF THE RADIOACTIVE PATIENT

procedures on patients who contain therapeutic quantities of radio-


active materials. The RSO should consider whether or not to
issue personal monitors to operating room staff. It is unlikely that
doses to operating room personnel from emergency surgeries will
approach the annual recommended limit of 5 mSv for infrequent
radiation exposures to individual members of the public. However,
rotation of operating room personnel should be considered in cases
where the individual effective dose is likely to exceed 1 mSv from
any single procedure. The number of persons in the operating room
should be minimized, and operating room personnel should only
remain in the operating room for the minimum amount of time con-
sistent with the surgical objectives.
In the case of treatment with radiopharmaceuticals, if it is esti-
mated that the circulating blood or the area of the body to be
treated surgically contains a significant quantity of the radiophar-
maceutical, the RSO and the surgeon should discuss the proce-
dures to be performed to keep radiation exposure to surgical
personnel ALARA. Standard precautions always used in sur-
gical settings will minimize the spread of radioactive contamina-
tion and the risk of internal contamination to operating room
personnel. Any surgical specimens sent for pathological examina-
tion should be monitored for contamination. Tools and other
equipment from the surgery should be monitored for radioactive
contamination, decontaminated as necessary, and stored for radio-
active decay or treated as radioactive waste. If an injury such as a
cut or puncture occurs or a glove is torn during surgery, radioactive
contamination of the skin or wound may occur. In addition to the
ordinary treatment and follow-up as with any wound, the RSO
shall be consulted to evaluate any possible radiation hazard, espe-
cially internal intake.

6.4 Patients on Dialysis

The administration of therapeutic doses of radiopharmaceuti-


cals to patients on dialysis raises special issues. These patients will
not clear radioactive materials as quickly as other patients, and the
clearance will generally not take place until the patient undergoes
a dialysis session. The decision as to the activity required for such
patients should be based on a trial administration of activity. Based
on the observed elimination rate, the appropriate total activity can
be administered to provide the radiation dose required for the
treatment. The largest amount of activity will usually be elimi-
nated during the first dialysis session with decreasing amounts
eliminated during subsequent sessions. The RSO should assess the

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6.5 TRANSFER TO ANOTHER HEALTHCARE FACILITY / 133

radiation exposures likely to be received by persons caring for the


patient during the dialysis sessions and issue personal monitors as
judged necessary. The materials, tubing, filters and waste contain-
ers, used during the dialysis session should be checked by the RSO
to see if these materials need to be removed as low-level radioactive
waste. The tubing, filters and waste containers should be stored for
decay and then disposed in an appropriate manner. The volume of
fluids used during these sessions should be sufficient to dilute the
radioactive concentrations to amounts below regulatory limits
for sewer discharge. Thus, these liquid wastes are being treated in
the same manner as patient excreta.

6.5 Transfer to Another Healthcare Facility

Subsequent to treatment, patients may be transferred to


another healthcare facility (i.e., another hospital, skilled nursing
facility, nursing home, or hospice). These patients would most
likely contain residual 131I from treatment of benign or malignant
thyroid disease or 125I/103Pd permanent interstitial seed implants.
Patients being transferred to another healthcare facility shall meet
the criteria for unrestricted release. The facility accepting the
transfer would not need a license for radioactive materials to
accept the patient although some facilities may possess such a
license. In the case of patients treated with radiopharmaceutical
therapy, the possibility for the generation of low-level radioactive
waste should be examined by the RSO of the treating facility and
any issues should be discussed with the facility accepting the
patient transfer. In the rare event that a patient being transferred
to another healthcare facility does not meet the criteria for unre-
stricted release, the RSO shall ensure that the admitting facility
has an appropriate license that will allow acceptance of the patient.
Many facilities have adopted the policy of issuing a wallet identifi-
cation card or other means of identification to patients who are
released while still containing measurable amounts of radioactive
material. Information on such identification documents should
include the radionuclide used and a telephone number at the treat-
ing facility that can be contacted on a 24 h basis, as necessary. The
healthcare institution receiving the patient may ask the treating
physician or the RSO of the treating institution to provide radia-
tion safety information and precautions, if any, for the patient and
for the receiving healthcare facility, including exposures to be
expected for personnel who care for the patient. Information pro-
vided in such cases should include precautions for minimizing
external radiation exposure. In the event of radiopharmaceutical

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134 / 6. CHANGES IN MEDICAL STATUS OF THE RADIOACTIVE PATIENT

administrations, most likely the use of 131I therapies, advice on the


use of standard precautions to minimize risk of internal contami-
nation should be given by the nuclear-medicine physician or the
RSO.

6.6 Readmission of Patients to the


Treating Institution

When a patient who still contains a therapeutic quantity of


radioactive material is readmitted to the treating hospital, the
RSO shall be notified as soon as possible after admission. In insti-
tutions treating significant numbers of patients, consideration
should be given to the addition of information on dates of cessation
of radiation precautions in electronic chart systems which could be
useful in the event of readmission. The RSO shall monitor the
patient and specify the precautions, if any, to be followed by
patient-care personnel. A new complete set of radiation precaution
tags should be placed on the patient, the patient’s room, and chart
at the time of this monitoring.

6.7 Death of the Patient

Therapeutic amounts of radioactive materials are not usually


administered to moribund patients, although there may be circum-
stances where the palliative use of radioactive materials in termi-
nal patients will significantly improve the quality-of-life of the
patient. The treating physician needs to weigh these quality-of-life
issues in making treatment decisions.

6.7.1 Death of the Patient Within a Treating Facility

In the rare event that a patient dies in the treating facility while
still containing a therapeutic quantity of radioactive material, the
treating radiation oncologist or nuclear-medicine physician and
the RSO shall be notified immediately. In the case of therapeutic
radiopharmaceuticals, if several days have elapsed between
radiopharmaceutical treatment and death, the radiation hazard
may be reduced considerably, and precautions, if any, for handling
the body may be minimal.

6.7.2 Removal of Temporary Implants

If the body contains a temporary implant, the radiation oncolo-


gist shall remove the sources prior to transfer of the body to the
morgue or funeral home. After the sources have been removed,

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6.7 DEATH OF THE PATIENT / 135

the RSO or designee shall perform a radiation survey to confirm


that no sources remain in the body or the hospital room. When it is
confirmed that all sources have been retrieved, postmortem care
can be initiated.

6.7.3 Death of the Patient Outside of the Treating Facility

In most cases, if a patient who has been treated with therapeu-


tic quantities of radioactive materials dies outside the treating
medical facility, no special precautions are generally necessary for
embalming or other preparation of the body for burial. Patients
treated with seed implants will not usually represent a radiation
hazard to persons dealing with the body unless there is to be an
autopsy or cremation (see Section 6.7.6 for precautions during
autopsy and Section 6.7.10 for a discussion of cremation of bodies
containing permanent implants). External exposure rates will be
minimal, and there is no radioactive contamination. For therapeu-
tic radiopharmaceutical administrations, radioactive contamina-
tion from body fluids will be minimal using standard aspiration
and injection methods for embalming. The treating physician
should instruct families of patients who receive >1 GBq of 131I that
if the patient expires within 2 d after receiving the treatment, the
pathologist or funeral-home personnel receiving the body should
seek advice from the treating physician or the RSO on methods to
keep their radiation exposures ALARA.

6.7.4 Organ Donation


If organ donation is a consideration, the RSO shall determine
necessary precautions for surgical personnel who will harvest the
organ(s). It is highly unlikely that the donated organ will contain a
quantity of radioactive material sufficient to cause significant
damage to the organ or deliver a radiation dose to the recipient
sufficient to nullify the donation. The radiation oncologist, nuclear-
medicine physician, or RSO should be prepared to provide esti-
mates of radiation doses that may be received by the recipient as
a result of the transplant. Because the organ donation may be a
life-saving event for the organ recipient or may significantly
improve the recipient’s quality-of-life, a limit for effective dose to
the recipient is not required. Any temporary implants shall be
removed from the body as expeditiously as possible to facilitate
organ harvesting. If a delay in removal of the temporary implants
is unavoidable, the RSO shall determine any interventions, such as
portable shielding, necessary to maintain personnel radiation
exposures ALARA.

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136 / 6. CHANGES IN MEDICAL STATUS OF THE RADIOACTIVE PATIENT

6.7.5 Permanent Implants and Radiopharmaceuticals

If the patient was treated with a permanent implant or with a


therapeutic amount of a radiopharmaceutical, the “radiation pre-
caution” wristband should remain on the body and an additional
tag should be placed on the outside of the shroud. If several days
have elapsed between the radiopharmaceutical treatment and
death, the radiation hazard will usually be reduced considerably,
and radiation safety precautions, if any, may be minimal. The
radioactive half-lives of radionuclides used in permanent implants
is usually sufficiently long such that the activity will not be reduced
significantly. In any event, the RSO shall notify the morgue prior
to the arrival of the body, and the RSO should discuss radiation
safety precautions with morgue personnel prior to postmortem
procedures.

6.7.6 Precautions During Autopsy

As long as the body remains unopened, any radiation exposure


received by personnel near the body will be due to gamma rays that
penetrate the body from the therapeutic radiation sources. In some
cases, the patient may have had a nuclear-medicine procedure
prior to death (e.g., a scan for pulmonary embolus) which may con-
tribute to the gamma dose rate. Nuclear-medicine records should
be checked by the RSO if this is suspected. Patients treated with
seed implants will have the radioactive source localized to the area
where the seeds were implanted. The RSO or radiation oncologist
can advise the pathologist where the seeds are located and that
area can be excised before the rest of the autopsy proceeds. Migra-
tion of seeds initially implanted in the prostate has been reported
in the literature (Merrick et al., 2000; Nag et al., 1997). The pathol-
ogist should be made aware of this possibility so that seeds found
outside the prostate can be excised if possible. The excised tissue
can be placed on a separate table. Sectioning of the excised
tissue can be done immediately with radiation safety assistance so
that any seeds can be removed from sections saved for pathological
examination. The excised area including the seeds can then be
replaced in the body at the conclusion of the autopsy. It should
be emphasized to pathology personnel that there is no contamina-
tion of body fluids with seed implants. However, it is possible to
slice through seeds during sectioning of an excised tissue. The
pathologist should be warned of this possibility and advised to pro-
ceed cautiously.

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6.7 DEATH OF THE PATIENT / 137

It is rare that the body of a patient will be delivered to autopsy


shortly after administration of a therapeutic radiopharmaceutical.
If death occurred shortly after administration (i.e., within 24 to
48 h) a considerable amount of activity will be present in blood and
urine. In such cases, the autopsy should be supervised by the RSO
or designee and personal monitors may be issued to pathology per-
sonnel according to the judgment of the RSO. Tissue samples taken
by the pathologist for analysis should be held until the activity has
decayed below measurable levels (e.g., for 10 half-lives). Determi-
nation of any residual activity in tissue samples should be made by
the RSO before release of the samples to the laboratory. If death
occurred at any time >48 h post-administration, it can be expected
that there will be little, if any, activity in blood or urine, and that
the activity will be present only in residual thyroid tissue, if any, or
in metastatic disease sites. Personal monitors may be issued to
pathology personnel according to the judgment of the RSO. Tissue
samples should be handled as described above.
In cases where the patient had received a dose of a beta-emit-
ting colloid (e.g., 32P chromic phosphate into a body cavity) activity
will have been deposited on serous surfaces with considerable
activity remaining in the cavity fluid. During autopsy as much fluid
as possible should be removed from body cavities before and imme-
diately after the body is opened. The fluid may be washed down the
drain in accordance with the instructions of the RSO. Adequate
protection against contamination is provided by following precau-
tions necessary for infection control (e.g., protective clothing,
gloves, etc.). Any beta radiation emitted by the source will be
largely absorbed in superficial tissues. Once the body cavity is
opened, however, the beta radiation can expose the pathologist and
others who assist in the autopsy. While beta radiation will not pen-
etrate more than a few millimeters into the skin, the dose to hands
may be significant because they will be in close contact with body
tissues and fluids (Laughlin, 1968). Autopsy personnel should wear
double gloves to reduce the hand dose from beta emitters. Safety
goggles should be worn to prevent an accidental splash into the
eyes. Goggles typically worn for the purpose of protecting against
blood-borne pathogen exposure are usually satisfactory. Specimens
from patients treated with radiopharmaceuticals may have to be
stored for decay before release for pathological examination. The
release of such specimens should be under the control of the RSO.

6.7.7 Preparation for Burial Without Autopsy or Embalming


If the attending radiation oncologist, nuclear-medicine physi-
cian, or RSO believes that the effective dose likely to be received by

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138 / 6. CHANGES IN MEDICAL STATUS OF THE RADIOACTIVE PATIENT

personnel preparing the body for burial without autopsy or


embalming will approach 5 mSv, the treating physicians or RSO
should provide radiation precaution information to the family of
the deceased. In most cases, precautions will be limited to restrict-
ing the time spent near the body to provide reasonable assurance
that family members will not receive >5 mSv effective dose.

6.7.8 Preparation for Burial by Embalming

The administering physician or RSO should notify the morgue


or funeral home that the body contains therapeutic quantities of
radioactive material and should provide personnel who embalm
the body with precautions to minimize radiation exposure and
radioactive contamination. If the maximal dose-equivalent rate at
30 cm from any surface of the body is <0.5 mSv h–1, no special pre-
cautions are necessary. Embalming is conducted by injecting an
embalming fluid into the body and flushing body fluids into the
drain. During the embalming of bodies that contain therapeutic
radiopharmaceuticals, personnel involved in the procedure should
follow precautions similar to those used for infection control (i.e.,
use of gloves and protective clothing) to avoid personal contamina-
tion. Careful cleaning of equipment in the usual manner will
remove radioactive contamination. When embalming bodies that
contain permanent implants such as 125I or 103Pd, personnel should
avoid standing next to the area of the body that contains the
implant. The RSO should discuss the exposure rates to personnel
involved in the embalming procedure and provide guidance on
the times and distances. It is recommended that the effective dose
to personnel be limited to 0.25 mSv per embalmed body.

6.7.9 Precautions During Visitation

In most cases, no precautions will be necessary during visita-


tion. If the possibility exists of measurable exposure rates at a dis-
tance of 30 cm from the body, the family should be given
appropriate advice that will provide reasonable assurance that
family members will not receive >5 mSv.

6.7.10 Cremation

Recommendations in this Section assume that the body has


been prepared in accordance with recommendations in the preced-
ing sections. No additional handling precautions are necessary
in transporting the body to the crematorium. In cases where the

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6.7 DEATH OF THE PATIENT / 139

radionuclide-therapy patient dies outside the treating facility, fam-


ilies should inform crematorium personnel that the body might
contain activity. Crematorium personnel should contact the radia-
tion oncologist, nuclear-medicine physician, or RSO if they want
additional guidance on handling the body. The physician may refer
the questions to the RSO who should also provide assistance in
decontamination of the crematorium, if necessary.
In cases where the patient dies in a hospital and still contains
significant quantities of radiopharmaceuticals, the RSO should
advise crematorium personnel that the body is radioactive and
should provide guidance on methods to minimize radiation expo-
sure, contamination of the retort, and especially methods to mini-
mize radioactive ash particles. Modern crematories use a
combination of high temperature and forced air to ensure complete
combustion of all soft tissues. The only residue consists of finely
divided bone ash. Therefore, several types of hazards should be
considered. The most likely hazard to the general population in the
vicinity of the crematorium is the inhalation of radioactive mate-
rial emitted with the stack gases. Crematorium employees may
receive external exposure from the radioactive body or from con-
tamination of the crematorium or internal exposure from inhala-
tion of radioactive particles while handling the ashes (Que, 2001;
Wallace, 1991).
The most likely exposure to members of the public would be
from cremation of a body that contained 131I. If a crematorium were
to handle bodies that contain a total quantity not exceeding
100 GBq in a single year, the effective dose to individuals in the
surrounding population would not be likely to exceed 0.1 mSv.
While the embalmed body of a radioiodine patient could contain as
much as several gigabecquerel of 131I, it is most likely that bodies
would contain significantly <0.1 GBq. Therefore, it appears that no
radiation hazard would exist even if a crematorium were to handle
several bodies per year containing 131I. Approximately 200,000
patients receive 131I therapy per year across the United States
(Hundahl, 1998). It is rare for a patient to die during treatment,
and it is highly unlikely that a single crematorium would handle
>10 bodies that contain therapeutic quantities of 131I.
Bodies that contain gamma-emitting radionuclides will result
in some external exposure to employees of the crematorium.
Because minimal time is required to handle the body at the crema-
torium, no precautions are necessary to protect from external radi-
ation exposure. Cremation of bodies that contain radionuclides
that are not volatile may result in contamination of the retort. The
most significant hazard from this contamination is inhalation of

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140 / 6. CHANGES IN MEDICAL STATUS OF THE RADIOACTIVE PATIENT

ash particles during cleaning of the retort. The presence of radioac-


tive seeds within a body scheduled to be cremated raises the issue
of whether such seeds will be intermixed with ashes upon comple-
tion of the process. Because of the very high temperatures used in
modern crematoria, it is most probable that the seeds themselves
will burst releasing any contained activity into the plume.
Some states and municipalities have proposed restrictions on
the number of bodies containing radioactive seeds to be accepted
for cremation at any one location or have proposed that the family
seek specific permission for cremation of such a body before the cre-
mation can actually take place (Que, 2001). If there are concerns on
the part of the family of the deceased about the potential for resid-
ual activity in the ashes of the deceased, the RSO of the treating
facility should be available for consultation and monitoring as
deemed necessary. Cremation of bodies that contained beta-emit-
ting radionuclides would be expected to create similar hazards. To
prevent significant inhalation of ash particles, workers who clean
the retort should wear dust masks and protective garments during
handling of the ashes and cleaning of the retort. It is unlikely that
any crematorium would in any 1 y handle a sufficient number of
radioactive bodies such that the radiation doses to workers or the
public would exceed 1 mSv. However, each crematorium should
maintain records of the type and activity in bodies cremated, when
known.

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Appendix A

Patient-Release
Criteria

Sections 3 and 4 of this Report contain patient-release criteria


in general terms. This Appendix is intended to present the analyt-
ical basis for calculating the pertinent exposure rates and related
dose quantities for implementing patient-release criteria applica-
ble to radiopharmaceutical therapy. Although the principles in this
Appendix can be applied to brachytherapy, this discussion deals
only with radiopharmaceutical therapy. Appendix B presents three
specific examples of the application of these principles.

A.1 Dosimetry

Two types of quantities are specifically defined for use in radio-


logical protection: protection quantities, which are defined by
ICRP, and operational quantities, which are defined by ICRU. The
most recent set of protection quantities recommended in ICRP
Publication 60 (ICRP, 1991) includes the effective dose (E) and the
tissue or organ equivalent doses (HT). These quantities are not
directly measurable but are amenable to calculation if the condi-
tions of irradiation are known.
Both the protection and operational quantities can be related
to the basic physical quantities exposure (X), air kerma (Ka), and
tissue absorbed dose (D) (NCRP, 1985). The physical quantities and
operational quantities are the basis for measuring external radia-
tion. Exposure (X) is defined as the quotient of dQ by dm, where dQ
is the absolute value of the total charge of the ions of one sign pro-
duced in air when all the electrons liberated by photons in air hav-
ing mass dm are completely stopped in air. Air kerma (Ka) is
defined as the quotient of dEtr by dm, where dEtr is the sum of the
initial kinetic energies of all the charged ionizing particles liber-
ated by uncharged ionizing particles in air having mass dm. The

141

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142 / APPENDIX A

absorbed dose (D) is the quotient of dε by dm, where dε is the


mean energy imparted by ionizing radiation to matter of mass dm.
The physical quantities and operational quantities are the basis for
measuring external radiation.
Conversion coefficients, which relate operational and protection
quantities to physical quantities, are calculated using radiation
transport codes and the appropriate mathematical models.

A.1.1 Physical Quantities

Measurements of the amount of photon radiation emitted from


patients are generally made with instruments that are calibrated
to indicate exposure (X) in roentgens (R). Instruments can also be
calibrated in air kerma (Ka) (ICRU, 1998a). Such measurements
are made at a point in a radiation field at some specified distance
from a patient or shielded enclosure.
The relationship between the quantities air kerma and expo-
sure for photons emitted from treated patients at energies applica-
ble to this Report (0.05 to 1 MeV) is as follows (NIST, 2001):

K a = 0.00876 X, (A.1)

where Ka is expressed in gray and X in roentgens. Alternatively, Ka


can be obtained by dividing X by 114.
For purposes of complying with appropriate shielding design
criteria for photons Ka is the recommended quantity (NCRP,
2004b). The absorbed dose (gray) to tissue located at that point is
obtained by multiplying the air kerma by 1.099, the mean tis-
sue-to-air mass-energy-absorption coefficient ratio for the applica-
ble photon-energy range (ICRU, 1993).

A.1.2 Operational Quantities

The absorbed dose (D) at the point of measurement can be mod-


ified to account for biological effectiveness of the various radiation
types and energies, yielding the operational quantity dose equiva-
lent (H) (sieverts) (ICRU, 1993). The dose equivalent (H) is product
of D, Q and N at the point of interest where D is the absorbed dose,
Q is the quality factor (assigned a value of one for photons), and N
is the product of all other modifying factors. For individual moni-
toring the quantity personal dose equivalent [Hp(d)] is the dose
equivalent in soft tissue, at an appropriate depth (d) below a spec-
ified point on the body (ICRU, 1993).

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A.1 DOSIMETRY / 143

A.1.3 Protection Quantities

Protection quantities were recommended and defined in ICRP


Publication 60 (ICRP, 1991) as well as in NCRP Report No. 82
(NCRP, 1985). These quantities include the organ absorbed dose
(D), organ equivalent dose (HT), and effective dose (E). The effective
dose, E, is defined as the sum of the weighted equivalent doses to
specific organs or tissues, HT [i.e., each equivalent dose is weighted
by the corresponding tissue weighting factor for the organ or tissue
(wT) (NCRP, 1993)]. The value of wT for a particular organ or
tissue represents the fraction of detriment (i.e., from cancer and
hereditary effects) attributed to that organ or tissue when the
whole body is irradiated uniformly. Tissue weighting factors are
assigned for 12 tissues and organs and a remainder for assignment
to other tissues and organs as necessary such that the sum of these
factors equals one. The equivalent dose to a specific organ or tissue
(HT) is obtained by weighting the mean absorbed dose in a tissue or
organ (see below) (DT) by a radiation weighting factor (wR) to allow
for the relative biological effectiveness of the ionizing radiation or
radiations of interest. Based on the radiation risks determined
from epidemiological and animal studies, values of E are assigned
as various effective dose limits (Elimit) for purposes of radiation
protection.
With the development of advanced calculational techniques of
interactions of radiations with matter (e.g., Monte-Carlo radiation
transport analysis), it is possible to estimate the relationship
between air kerma and effective dose using conversion coefficients
that are published in ICRU Report 57 (ICRU, 1998b). These calcu-
–1
lations provide the effective dose per unit of air kerma (E K a ) (in
–1
Sv Gy ) for monoenergetic photons in various geometries incident
on an adult anthropomorphic computational model. The geome-
tries published are anterior-posterior, posterior-anterior, right- and
left-lateral, rotational (ROT) and isotropic (ISO). The last two
geometries, ROT and ISO, are most applicable to this Report
because individuals will be moving around when interacting with
–1
a treated patient. The average of values for E K a for the energy
range 0.05 to 1 MeV is 0.846 for ROT and 0.682 for ISO. The con-
version equation (ICRU, 1998b) for effective dose (in sieverts) is:

–1 –1
E = K a ( E K a ) = 0.00876 X ( E K a ), (A.2)

–1
where E K a is the effective dose per unit air-kerma conversion
coefficient as a function of photon energy and radiation geometry.
Then, for the two applicable geometries (ICRU, 1998b):

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144 / APPENDIX A

E ROT = ( 0.00876 X ) 0.846 = 0.00741 X, (A.3)

E ISO = ( 0.00876 X ) 0.682 = 0.00597 X. (A.4)

Alternatively, EROT and EISO can be obtained by dividing X by 135


and 168, respectively.
Both geometries are given for illustration purposes. For a spe-
cific situation, the applicable photon energy can be used and the
appropriate geometry chosen. Thus, a conservatively safe assump-
tion is that the measured or calculated value of Ka, determined
directly or using the measured exposure X, will be an overestimate
of the effective dose E for the exposed individual.
As a practical example, Sparks et al. (1998) have investigated
the use of 131I in radioimmunotherapy patients. Their Monte-Carlo
analysis indicates that the numerical value for effective dose equiv-
alent (the predecessor quantity to effective dose) at 1 m is only 62 %
of the measured absorbed dose in air (Da) at 1 m.

A.2 Exposed Groups and Dose Limits

In Report No. 37 and Commentary No. 11 (NCRP, 1970; 1995a),


NCRP considered the radiation doses to family members and oth-
ers in the vicinity of a patient treated with radiopharmaceutical
therapy and brachytherapy. Those recommendations formed the
basis of the recommendations of Regulatory Guide 8.39 (NRC,
1997) and its successor document, NUREG-1556 (NRC, 1997;
2005). A “family member” may be any person who spends a sub-
stantial amount of time in the company of the patient on a regular
basis, providing support and comfort, and whom the patient consid-
ers a member of their “family,” whether by birth, by marriage, or by
virtue of a close, caring relationship (NCRP, 1995a). Members of a
patient's family can and should be considered as distinct from
members of the public in many respects, including the application
of radiation protection standards. Standards for family members of
radionuclide therapy patients should not be as restrictive as those
for members of the public because family members receive benefits
associated with treatment of the patient and they accept their radi-
ation burden as explained by the treating physician.
Radionuclide therapies are generally employed no more than
several times during a patient's lifetime, and family members of
patients receiving such therapies should, therefore, be considered
as being exposed infrequently, with a recommended annual effec-
tive dose limit (Elimit) of 5 mSv (NCRP, 1993b).5 In addition, in

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A.2 EXPOSED GROUPS AND DOSE LIMITS / 145

Commentary No. 11, NCRP recommended that an adult member of


the patient’s family be permitted to receive up to 50 mSv y–1 on the
recommendation of the treating physician (NCRP, 1995a).6
Although an endorsement of the 5 mSv y–1 limit specified in NRC’s
Regulatory Guide 8.39 (NRC, 1997) is not implied or intended, this
value of the Elimit is used in the development of the analytical basis
described in this Appendix.
A “member of the public” may be any individual who is not
a patient undergoing treatment, is not a family member of such a
patient, and is not an occupationally-exposed individual participat-
ing in the care and management of such a patient. Members of the
public include other patients in the medical facility in which
the patient may be confined, the patient's co-workers, and other
individuals with no familial connection to the patient. Use of the
1 mSv y–1 limit for members of the public and for children and preg-
nant women in the patient’s family is consistent with the limits rec-
ommended for these groups by NCRP (1995a). It should be noted
that the foregoing limits are annual totals and, therefore, do not
apply to individual treatments of a patient but collectively to all
treatments a patient may receive in a given year (NCRP, 1993b;
1995a).
The practical requirement in protecting a person from the radi-
ation emitted by a patient is to determine the effective dose, as dis-
cussed above, during the period of time when the exposure rate
from the patient is significant. The effective dose then is the prod-
uct of the effective dose rate and the period of exposure. Because
the exposure rate from the patient is continuously decreasing with
time from radioactive decay and from biological elimination of the
radionuclide, the effective dose rate is also continuously decreasing
and appropriate mathematical calculation is required as discussed
in the analytical presentation that follows.
In 1996 NRC analyzed the practical consequences of a relax-
ation of the regulatory requirements for medical confinement of
radionuclide therapy patients (NRC, 1997a). The conclusions of this
analysis were that projected dose-based release criteria, in replac-
ing the long-standing activity-based criteria, would not pose a sig-
nificant radiation risk to the public and would result in outpatient

5
Corresponds to the effective dose limit for infrequent exposures of the
public recommended in NCRP Report No. 116 (NCRP, 1993b).
6NCRP Statement No. 10 (NCRP, 2004a) and NCRP Commentary
No. 11 (NCRP, 1995a) recommend this upper limit for nonpregnant adults
on recommendation of the treating physician provided these persons
receive appropriate training and individual monitoring.

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146 / APPENDIX A

treatment of many radionuclide therapy patients who would other-


wise require hospitalization. Shortly thereafter, NRC codified new
release criteria described in Regulatory Guide 8.39 for radionuclide
therapy patients (NRC, 1997b). A sizable literature rapidly
emerged on their practical implementation. An algorithm was
developed by Gates et al. (1998) and by Siegel (1998) for therapy of
non-Hodgkin’s B-cell lymphoma with 131I-labeled anti-B1 mono-
clonal antibody. The total-body clearance of this agent followed
mono-exponential kinetics, that is, the total-body time-activity
could be described mathematically by a single exponential term
(Gates et al., 1998; Siegel, 1998). With noted exceptions, such an
approach had not appeared previously in the scientific literature
(Barrington et al., 1999; Cormack and Shearer, 1998). This new
approach was expanded by Zanzonico et al. (2000) who presented a
generalized algorithm for determining the time of release and the
duration at home of post-release radiation precautions following
radiopharmaceutical therapy. The Elimit for some groups used in the
development of this algorithm differs from previous recommenda-
tions of NCRP. For each type of group of exposed or potentially
exposed individuals, the most conservatively safe (i.e., the lowest)
Elimit value stipulated or recommended has been used.

A.3 Occupancy Factors and Index Distances

Important in the estimation of effective dose are two interre-


lated parameters: the occupancy factor and what has been termed
the “index distance” (NRC, 2002). The occupancy factor ( T r ) at an
j
index distance, rj, from a radioactive patient is the fraction of time
an individual spends at the index distance from the patient such
m
that ∑ Trj = 1 . This relation represents the sum over all index
j=1
distances up to a maximal distance rm from the patient. For every-
day activities, the index distance is set at 1 m. The mean index dis-
tance between sleeping partners and between a child and an
individual holding the child is set at 0.3 m. Such index distances
are, of course, difficult to establish precisely and are inevitably
somewhat arbitrary, but the distances appear to be consistent with
the limited anthropological data available (Culver and Dworkin,
1991; 1992; Hall, 1966; Siegel, 1998). However, the algorithm does
not depend on any specific values of occupancy factors and index
distances. The parameters shown in Table A.1 and the related
equations that follow can be modified as deemed appropriate.

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A.4 OPERATIONAL EQUATIONS / 147

When not specifically in the company of the radioactive patient,


an individual will be at distances well beyond the index distance of
1 m. Because of the rapid decrease in exposure rate with distance
from the patient, for distances other than or farther from the radio-
active patient than these specified index distances, the exposure
rates may be considered negligibly small. Accordingly, in practice,
distances other than the specified index distances and the associ-
ated occupancy factors shown in Table A.1 are not explicitly consid-
m
ered and, therefore, ∑ Trj ≠ 1 .
j=1

A.4 Operational Equations

The time-dependent effective dose rate at an index distance rj


from a patient containing activity may be approximated using the
following equations (Zanzonico, 2000):7

TABLE A.1—Occupancy factors, index distances, and


effective dose limits.

Occupancy Index Effective Dose


Group/Activity
Factors Distances (m) Limits (mSv)

Members of patients’ family:

Nonsleeping 0.25 1.0 5


partner/adult

Nonpregnant sleeping 0.33 0.3 5


partner

Pregnant sleeping 0.33 0.3 1


partner

Pregnant 0.25 1.0 1/1


women/children

Child held by patient 0.20 0.3 1

Public: Co-worker 0.33 1.0 1

7
Equations A.5 to A.12 have all been adapted from Zanzonico (2000).

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148 / APPENDIX A

· · –1
Ε ( rj , t ) = K a ( rj , t ) ( E K a ) (A.5)
– 0.693t
n ----------------------
· –1 Te
= ∑ K a ( r j , 0 ) i ( E K a )e i ,
i=1
where:
·
Ε ( r j , t ) = effective dose rate (mSv h–1) at an index distance
rj (meters) from the patient at time t post-adminis-
tration (days)
·
Ka ( rj , t ) = air kerma rate (Gy h–1) at an index distance rj
(meters) from the patient at time t post-administra-
tion (days)
–1
E Ka = effective dose per unit air kerma conversion coeffi-
cient (Sv Gy–1)
·
Ka ( rj , 0 )i = zero-time intercept of exponential component i of
the time-dependent air kerma rate measured at an
index distance rj (meters) from the patient
T ei = effective half-life (days) of the nondecay corrected
total-body activity for compartment i of a multi-
exponential function
n = number of exponential components required to
describe the time-dependent total-body activity

Implicit in Equation A.5 is the overestimation approximately by a


factor of two, previously described, when using the air kerma rate
that is actually measured in practice and that applies throughout
the analysis that follows. Also, implicit in Equation A.5 is the
assumption that the time-dependent total-body activity follows a
multi-exponential function:
– 0.693t
n ----------------------
Te
A( t) = A(0) ∑ Fi e i , (A.6)
i=1
where:

A(t) = total-body activity (becquerels) at time t post-


administration (days)
Fi = zero-time intercept of exponential component i of
the total-body activity expressed as a fraction of the
n
administered activity such that ∑ Fi =1
i=1

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A.4 OPERATIONAL EQUATIONS / 149

The foregoing activities are decay corrected, that is, the activity is
corrected for radioactive decay back to the time of administration.
In principle, each of the exponential components represents a met-
abolic compartment and its effective half-life is related to the rate
of clearance of activity from that compartment.
In addition, implicit in these equations is the assumption that
activity is being continuously eliminated from the patient’s body
from the time of administration. Of course, no activity is biologi-
cally eliminated from the body before the patient’s first void or def-
ecation post-therapy. Within these first several hours post-therapy,
the only means of elimination of activity is physical decay. Various
authors account for this by appending an effective dose contribu-
tion term with an effective half-life equal to the particular radionu-
clide’s physical half-life (Gates et al., 1998; NRC, 2002; Siegel,
1998). The duration of time during which an effective half-life is
equal to the radionuclide’s physical half-life is taken as 8 h for
orally administered radiopharmaceuticals such as 131I-labeled
sodium iodide but only 3 h for intravenously administered radio-
pharmaceuticals such as 131I anti-B1 monoclonal antibody (Gates
et al., 1998; NRC, 2005; Siegel, 1998). The 8 h period may be overly
conservative (in the safe direction), because gastric emptying and
overall gastrointestinal elimination of orally administered radio-
pharmaceuticals in liquid form will likely occur earlier than 8 h. An
alternative approach, implicitly represented in the equations
above, is that the patient remains in the hospital until the first
post-therapy void/defecation or for some designated time by which
the activity in the stomach following oral administration would
have dramatically decreased. The decision as to choice of this time
is somewhat arbitrary, but a minimal time of 2 h would seem pru-
dent. This approach may require an appropriately designed room
in which to house the radioactive patient immediately following
administration of the therapeutic activity. This room may have to
be a dedicated facility depending on the patient volume. The room
should be supplied with portable or fixed shielding to reduce the
dose levels in the surrounding areas to public levels. Consideration
should be given to shielding of waste collection cans and areas for
performing release surveys. Special design considerations should
be reviewed with a qualified medical physicist.
The values of the parameters, Fi and T e i , of the multi-exponen-
tial function in Equation A.6 may be obtained from sources in
the pertinent scientific literature or, preferably, be determined
empirically for individual patients by performing serial measure-
ments of the total-body activity following a pretherapy tracer
administration of the therapeutic radiopharmaceutical and mono-

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150 / APPENDIX A

or multi-exponential curve-fitting of the resulting time-activity


data (Zanzonico, 1995). Following determination of the Fi and T ei ,
Equation A.5 may then be rewritten as:
– 0.693t
n ----------------------
· · –1 Te
Ε ( rj , t ) = K a ( rj , 0 ) ( E K a ) ∑ Fi e
i
. (A.7)
i=1

Thus, the effective dose at an index distance rj from a radioactive


patient from time t1 to time t2 post-administration is given by the
following equation as:
t2 – 0.693t
n ----------------------
· –1 Te
∑ ∫
i
E ( r j ) t → t = 24 T rj K a ( r j , 0 ) ( E K a ) Fi e dt, (A.8)
1 2
i = 1 t1

where:

E ( r j ) t → t = effective dose (millisieverts) at an index distance rj


1 2
from the patient from time t1 to time t2 post-admin-
istration (days)
–1
E Ka = effective dose per unit air kerma conversion coeffi-
cient (Sv Gy–1)
T rj = occupancy factor for an individual at a distance rj
(meters) from a radioactive patient
24 = factor for conversion of time in days to time in
hours

Equation A.8 may be generalized to yield the effective dose from a


radioactive patient from time t1 to time t2 ( E t → t ) post-adminis-
1 2
tration including all possible occupancy factors as:

t2 – 0.693t
n ----------------------
m Te
· –1
∑ ∑ ∫
i
E t → t = 24 T rj K a ( r j , 0 ) ( E K a ) Fi e dt. (A.9)
1 2
j=1 i = 1 t1

By substituting t1 = 0 and t2 = into Equation A.9 and evaluating the


resulting definite integral8 the effective dose from the patient over
all time can be obtained as:

t2 – 0.693t
n ---------------------- n
Te
∑ ∫ ∑ Fi Tei where the factor 1.44
8Note
that Fi e i dt = 1.44
= 1/0.693. i = 1 t1 i=1

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A.4 OPERATIONAL EQUATIONS / 151

m n
· –1
E = 24 ∑ T r j K a ( r j , 0 ) ( E K a ) 1.44 ∑ F i T ei (A.10)
ϕ=1 i=1
m
· –1
= 24 τ ∑ K a ( rj , 0 ) ( E K a ) Trj ,
j=1
where:

τ = the residence time (days) of activity in the patient


n
= 1.44 ∑ F i T ei
i=1

When the patient is to be released from medical confinement, the


effective dose for any person associated with the patient arising
from the air-kerma rate of such a patient at the release time
(trelease), shall not exceed the applicable dose limit. The time of
release [(trelease)limit], then becomes the controlling factor in deter-
mining the effective dose at time of release [E(trelease)limit], that is to
be compared to the effective dose limit (Elimit). Thus, by substituting
t1 = (trelease)limit and t2 = ∞, Equation A.9 becomes:
– 0.693 ( t release )
limit
m n ---------------------------------------------------
-
· –1 Te
E limit = 34.6 ∑ Trj K a ( rj , 0 ) ( E K a ) ∑ T ei F i e i (A.11)
j=1 i=1

for the whole period after release, where 34.6 = 1.44 × 24, a factor
for calculating residence time (τ) (hours), from the fractional zero-
time intercepts (Fi), and the effective half-lives ( T ei ) (days).
Equation A.11 cannot be solved analytically for the parameter
(trelease)limit, that is, Equation A.11 cannot be solved to provide an
explicit formula for the parameter (trelease)limit for a multi-exponen-
tial total-body time-activity function (Cormack, 1998). However,
the time post-administration for release of the patient from
medical confinement, t1 = (trelease)limit, and the duration of various
radiation precautions may be determined “iteratively” from
Equation A.11. If the effective dose (E) at an index distance of 1 m
from the radiopharmaceutical therapy or brachytherapy patient as
given by Equation A.11 does not exceed the effective dose limit of
5 mSv, the patient may be released after administration of the ther-
apeutic radiopharmaceutical or implant following the restrictions
on a first void and time restrictions as discussed previously. If, how-
ever, E at an index distance of 1 m from the radiopharmaceutical

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152 / APPENDIX A

therapy or brachytherapy patient as given by Equation A.11 does


exceed the effective dose limit of 5 mSv, possible values of the time
post-administration of release of the patient from medical confine-
ment [(trelease)0.5 cSv] may be substituted into the right side of Equa-
tion A.11. Beginning with a time of 1 d and substituting time
values in 1 d increments, the smallest time value (1 d, 2 d, 3 d...)
that yields an effective dose by Equation A.11 equal to or less than
the dose limit is the time post-administration of release of the
patient from medical confinement [(trelease)limit]. Similarly, the dura-
tion in terms of times post-administration of the post-release radi-
ation precautions [i.e., not working (tno work), avoiding pregnant
women and children (tavoid), limiting holding of children (tno hold), and
sleeping partners not sleeping together (tsleep apart)] may be deter-
mined with Equation A.11 by substituting the dose limits applica-
ble to the respective groups and the corresponding index distances
(rj), occupancy factors ( T r ), and measured zero-time air kerma
j
·
rates [ K ( r j ,0 ) ]. Increments shorter than 1 d may be used for this
calculation. Depending on the group(s) of interest, which in turn
depends on the circumstances of the individual patient, the perti-
nent values of the effective-dose limits, the index distances (rj) and
the occupancy factors ( T r ) will vary and the exact form of Equa-
j
tion A.11 will, therefore, vary as well. It can be useful to calculate
these times using a computerized spreadsheet program.
For a therapeutic radiopharmaceutical for which the time-
dependent total-body activity follows a mono-exponential function
(i.e., in Equation A.5, n = 1) Equation A.11 can be expressed as:

– 0.693 ( t release )
m limit
· –1 -------------------------------------------------------
-
T
E limit = 34.6 ∑ T rj K a ( r j , 0 ) ( E K a ) T e e e , (A.12)
j=1

where:

Te = effective half-life of the nondecay-corrected total-


body activity for a single exponential function

Mono-exponential total-body time-activity functions apply, at least


approximately, to many therapeutic radiopharmaceuticals. In con-
trast to Equation A.11, Equation A.12 can be solved explicitly for
(trelease)limit, the time of release from medical confinement following
radionuclide treatment.

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A.4 OPERATIONAL EQUATIONS / 153

Use of the appropriate group-dependent effective-dose limits,


index distances (rj), and occupancy factors ( T r ), the practical forms
j
of Equation A.11 (i.e., the so-called “general operational equations”
for multi-exponential clearance) can be used to determine the times
post-radiopharmaceutical treatment for release from medical con-
finement [t(release)limit], not working (tno work), avoiding pregnant
women and children (tavoid), limiting holding of children (tno hold), and
sleeping partners not sleeping together (tsleep apart) (Table A.2).
In addition, Equation A.12 has been solved explicitly, yielding
the so-called “special operational equations” for the corresponding
times post-radiopharmaceutical treatment for mono-exponential
clearance (Table A.3).
In Tables A.2 and A.3, the second main entry “Members of
Patients Family” has two subentries: (1) “all activities except sleep-
ing with the patient” and (2) “sleeping with the patient.” The
patient then has a choice that must be made before being released
so that the dose calculation can be made and the results entered in
the instruction sheets of Appendix B. Both Options 1 and 2 can be
analyzed and the sums of the two associated doses shall not exceed
the dose limit of 5 mSv. Alternatively, the patient can choose to use
the longer time, trelease or tsleep apart, resulting from each of the options
to meet the dose limit.
If it is deemed appropriate by the physician in consultation with
the RSO that a patient is not suitable for release following
same-day treatment, then the patient should be admitted to the
medical facility (Section 3). In these cases, the exposure-rate crite-
ria for release should be consistent with both licensing restrictions
and regulatory dose limits.

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TABLE A.2—General operational equations for multi-exponential retention of therapeutic radiopharmaceuticals.a
Determination of time post-radiopharmaceutical treatment of release from medical confinement [(trelease)limit],
of not working (tno work), of avoiding pregnant women and children (tavoid), of limiting holding of children (tno hold), and
of sleeping partners not sleeping together (tsleep apart).

Effective-
Index Occupancy
Group/Activity Dose Limit Operational Equation for Determining Specified Time (d)a
Distance (m) Factor
(cSv)
154 / APPENDIX A

Nonpregnant Adult

Members of patient’s family

– 0.693(t )
release 0.5 cSv
n ----------------------------------------------------
· –1 Te
Nonsleeping partner 1 0.25 0.5 0.5 = 8.64 K a (1, 0) ( E Ka ) i
∑ T ei Fi e
i=1

Sleeping partner

– 0.693(t )
release 0.5 cSv
n ----------------------------------------------------
· –1 Te
All activities except 1 0.25 0.5 = 8.64 K a (1, 0) ( E Ka ) i

sleeping with patient


∑ T ei Fi e
i=1

plus/orb 0.5 plus/or

– 0.693(t sleep apart )


n ---------------------------------------------
-
· –1 Te
Sleeping with patient 0.3 0.33 0.5 = 11.4 K a (0.3, 0) ( E Ka ) i
∑ Tei Fi e
i=1

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Members of general public

– 0.693(t no work )
n ----------------------------------------
-
· –1 Te
Coworker 1 0.33 0.1 0.1 = 11.5 K a (1, 0) ( E Ka ) i
∑ T ei Fi e
i=1

Pregnant Women

Member of general public or patient’s family

– 0.693(t avoid )
n -----------------------------------
-
· –1 Te
Nonsleeping partner 1 0.25 0.1 0.1 = 8.64 K a (1, 0) ( E Ka ) i
∑ T ei Fi e
i=1

Member of patient’s family

Sleeping partner

– 0.693(t release )
0.1 cSv
n ---------------------------------------------------
-
· –1 Te
All activities except 1 0.25 0.1 = 8.64 K a (1, 0) ( E Ka ) i

sleeping with patient


∑ T ei Fi e
i=1
A.4 OPERATIONAL EQUATIONS

plus/orb 0.1 plus/or


/ 155

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TABLE A.2—(continued).
Effective-
Index Occupancy
Group/Activity Dose Limit Operational Equation for Determining Specified Time (d)a
Distance (m) Factor
(cSv)

– 0.693(t sleep apart )


n ---------------------------------------------
-
156 / APPENDIX A

· –1 Te
Sleeping with patient 0.3 0.33 0.1 = 11.4 K a (0.3, 0) ( E Ka ) i
∑ Tei Fi e
i=1

Members of general public

– 0.693(t no work )
n ----------------------------------------
-
· –1 Te
Coworker 1 0.33 0.1 0.1 = 11.5 K a (1, 0) ( E Ka ) i
∑ T ei Fi e
i=1

Children

– 0.693(t release )
n --------------------------------------
· –1 Te
All activities except 1 0.25 0.1 = 8.64 K a (1, 0) ( E Ka ) i

patient holding child


∑ T ei Fi e
i=1

plus/orb 0.1 plus/or

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– 0.693(t no hold )
n ---------------------------------------
· –1 Te
Patient holding child 0.3 0.2 0.1 = 7.2 K a (0.3, 0) ( E Ka ) i
∑ Tei Fi e
i=1

a
Equations adapted from Zanzonico (2000).
bThe
“plus/or” indicates two choices in meeting the dose limit. In one, the sums of the doses from the two equations for the same times or
different times shall not exceed the dose limit. Alternatively, the patient can choose the longest time, trelease or tsleep apart, resulting from
each of the options to meet the dose limit.
A.4 OPERATIONAL EQUATIONS
/ 157

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TABLE A.3—Special operational equations for mono-exponential retention of therapeutic radiopharmaceuticals.a
Determination of time post-radiopharmaceutical treatment of release from medical confinement [(trelease)limit],
of not working (tno work), of avoiding pregnant women and children (tavoid) of limiting holding of children (tno hold), and
of sleeping partners not sleeping together (tsleep apart).

Effective-
Index Occupancy
Group/Activity Dose Limit Operational Equation for Determining Specified Time (d)a
Distance (m) Factor
(cSv)
158 / APPENDIX A

Nonpregnant Adult

Members of patient’s family

· –1
Nonsleeping partner 1 0.25 0.5 ( t release ) = 1.44 T e ln [ 1.72 K a ( 1, 0 ) ( E Ka )T e ]
0.5 cSv

Sleeping partner

All activities except 1 0.25


sleeping with patient

· –1
K ( 0.3,0 ) ( E K )
a a
plus/orb,c 0.5 t sleep apart = 1.44 T e ln ---------------------------------------------------------------------------------------------------
-
– 0.693(t release )
0.5 cSv
----------------------------------------------------------
-
· –1 Te
----------------
0.029-
– 0.33 K a ( 1,0 ) ( E Ka )e
T
e

Sleeping with patient 0.3 0.33

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Members of general public

· –1
Coworker 1 0.33 0.1 t no work = 1.44 T e ln [ 86.4 K a ( 1, 0 ) ( E Ka )T e ]

Pregnant Women

Members of general public or patient’s family

· –1
Nonsleeping partner 1 0.25 0.1 t avoid = 1.44 T e ln [ 86.4 K a ( 1, 0 ) ( E Ka )T e ]

Member of patient’s family

Sleeping partner

All activities except 1 0.25


sleeping with patient

· –1
K ( 0.3,0 ) ( E K )
a a
plus/orb,c 0.1 t sleep apart = 1.44 T e ln ----------------------------------------------------------------------------------------
-
– 0.693(t )
avoid
----------------------------------------
0.0058 –1 Te
-------------------- – 0.33 K· a ( 1,0 ) ( E Ka )e
T
A.4 OPERATIONAL EQUATIONS

Sleeping with patient 0.3 0.5


/ 159

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TABLE A.3—(continued).

Effective-
Index Occupancy
Group/Activity Dose Limit Operational Equation for Determining Specified Time (d)a
Distance (m) Factor
(cSv)

Members of general public


160 / APPENDIX A

· –1
Coworker 1 0.33 0.1 t no work = 1.44 T e ln [ 86.4 K a ( 1, 0 ) ( E Ka )T e ]

Children

All activities except 1 0.25


patient holding child

· –1
K ( 0.3, 0 ) ( E K )
a a
plus/orb,c 0.1 t no hold = 1.44 T e ln --------------------------------------------------------------------------------------
-
– 0.693(t avoid )
----------------------------------------
· –1 Te
----------------
0.014-
– 1.2 K a ( 1, 0 ) ( E Ka )e
T
e

Patient holding child 0.3 0.2


a
Equations adapted from Zanzonico (2000).
bThe “plus/or” indicates two choices in meeting the dose limit. In one, the sums of the doses from the two equations for the same times or
different times must not exceed the dose limit. Alternatively, the patient can choose the longest time, trelease or tsleep apart, resulting from
each of the options to meet the dose limit.
cFor mono-exponential retention, only one equation applies in the dose calculation for each subentry, but different values are entered for

index distance and occupancy factor.

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Appendix B

Examples of the
Application of the
Operational Equations
Given in Appendix A

To facilitate the understanding of the operational equations


presented in Appendix A, several examples illustrating the practi-
cal application of these equations have been formulated and are
presented in this Appendix.9 The spreadsheets10 for the examples
that follow include pertinent numerical data and dosimetry results
based on all the assumptions and equations presented in
Appendix A. These illustrations are intended as examples only and
should not be taken to imply that the treatments described are

9Although
SI units are used in the Report, conventional units are used
in certain instances of this Appendix to enhance the practical usability of
the information presented.
10The spreadsheet file used for calculating the numerical values in the
Appendix B examples is provided as professional information for educa-
tional purposes only. The spreadsheet file is a nonvalidated calculation
tool for which there is absolutely no guarantee or warranty of fitness for a
particular purpose or any purpose expressed or implied. Any user of infor-
mation contained herein assumes any and all responsibility and liability
for use of the information including any misunderstanding, misuse or
misapplication of the information. Any use of this spreadsheet file is “as
is” and should only follow the user’s independent confirmation that it pro-
duces valid results for the user before results are used for any purpose
whatsoever. In no event shall the authors of the NCRP Report or NCRP
itself be liable for any incorrect or invalid results that are obtained by any
use of this spreadsheet file nor shall the authors or NCRP be liable for
any loss of data, or profits or special, incidental, indirect or consequential
damages arising out of or in connection with the use or performance of
this spreadsheet file.

161

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162 / APPENDIX B

either directly or indirectly applicable to any patient. The decision


as to the amount of activity to administer to a particular patient
remains the responsibility of the prescribing physician.
In the following examples, note that patients can be released
from the hospital on the day of treatment or 1 or 2 d later. However,
there can be sufficient activity in the patients with half-lives
long enough to require the observance for many days of the instruc-
tions to be performed after release, especially at home (i.e., the
duration for the instructions and actions can be extended over a
period of time and the period will depend on the particular treat-
ment situation).
Patients should be asked to acknowledge the instructions pro-
vided by the facility, preferably in writing (e.g., by signing a release
form of the type suggested at the end of the instructions for each
example). Also the patients should be given a copy of the instruc-
tions, including the copy of the release form.

B.1 Example 1: Metastatic Thyroid Cancer

In Example 1, a post-thyroidectomy and post-radioiodine abla-


tion patient with metastatic thyroid cancer has been treated with
an administered activity of 6,475 MBq (175 mCi) of 131I as sodium
iodide. Based on kinetic measurements of a pretherapy administra-
tion of a 74 MBq (2 mCi) 131I sodium-iodide tracer, this patient was
found to exhibit a bi-phasic (bi-exponential) retention function (i.e.,
total-body time-activity function), eliminating 95 % of the adminis-
tered activity with an effective half-life of 0.32 d and the remaining
5 % with an effective half-time of 5.8 d, yielding an 131I “residence
time” of 0.86 d = 20.5 h. In the literature on internal radionuclide
dosimetry, the quantity cumulated activity in an organ is some-
times used in place of the quantity residence time (τ), equivalent to
the cumulated activity ( Ã ) per unit administered activity (AA):

à Ai
τ = ----------- = 1.44 ∑ - T = 1.44 ∑ F i T e
---------- (B.1)
AA AA ei i
i i

where:

T ei = effective half-life

Fi = fraction of the administered activity at time t = 0 for


the ith exponential component of the time-activity
function in the organ

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B.1 EXAMPLE 1: METASTATIC THYROID CANCER / 163

Therefore, Ã = AA τ is units of s–1. Immediately following adminis-


tration of the 74 MBq (2 mCi) tracer, exposure rates were measured
with a survey meter, yielding 0.26 and 3 mR h–1 at 1 and 0.3 m,
respectively.
Accordingly, because all of the Column 1 values in the spread-
sheet are <5 mSv this patient could be released on the same day
the treatment was administered. However, the patient should
avoid holding small children for >10 min d–1 for 21 d post-treat-
ment, and only if the patient avoided the children altogether
during the first day after treatment when the patient was the most
radioactive and, therefore, producing the highest exposure rate.
This restriction is necessitated by the fact that the values in the
“1 d” subcolumn in Column 6 do not decrease to <1 mSv until after
day 21 post-treatment. As indicated in the other subcolumns
in Column 6, this “child-avoidance” period is shortened somewhat
if the patient avoided children altogether for longer than 1 d imme-
diately post-treatment. Conversely, if the patient did not avoid
children during that first day post-treatment, the subsequent
“child-avoidance period is much longer, as the values in the “0 d”
subcolumn in Column 6 do not decrease to <1 mSv even up to day
40 post-treatment.
Because all of the Column 4 values after the first day post-
treatment are <1 mSv, the patient can return to work on day two
post-treatment. Likewise, the general radiation precautions at
home need to be observed only for the first day post-treatment sub-
ject to the other dose restrictions. On the other hand, the patient
should not sleep in the same bed with a sleeping partner until 7 d
after treatment, as the values in the “0 d” subcolumn in Column 3
do not decrease to <5 mSv until day seven post-treatment. How-
ever, if the patient's sleeping partner is pregnant, her dose limit is
lowered to 1 mSv and the patient should, therefore, not sleep in the
same bed until 24 d after treatment, and only if he avoided his
sleeping partner altogether during the first day after administra-
tion of the radiopharmaceutical therapy, as the values in the “1 d”
subcolumn in Column 3 do not decrease to <1 mSv until after 24 d
post-treatment.
The spreadsheet and instructions for this patient are on the fol-
lowing five pages (Zanzonico et al., 2000).

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164 / APPENDIX B

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B.1 EXAMPLE 1: METASTATIC THYROID CANCER / 165

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166 / APPENDIX B

Example 1: Instruction Sheets


Radiation Safety Precautions for
Radiopharmaceutical Therapy Patients
Note: Please carefully read and follow the instructions in this
document.

If you or your health care provider have any questions or con-


cerns regarding the radionuclide therapy you have received, please
contact:
Dr. J. Smith
Nuclear Medicine Attending Physician
at (111) 222-3333
Telephone Number
or 0000
Emergency or Pager Telephone Number

Patient John Q. Patient , Medical Record Number 111-11-111 ,


received a therapeutic dose of 6.475 MBq (175 mCi) of Iodine-131
Sodium Iodide at General Hospital on January 1, 2004 at
9:00 am and should observe the following radiation safety precau-
tions at home as follows.
F Avoid close contact [less than 1 meter (3 feet) away from]
with pregnant women and children until 1 day after the
administration of the radionuclide therapy.
F Do not hold or embrace children for more than 10 minutes
a day until 21 days after the day your radionuclide ther-
apy was administered. This requires that you avoid contact
with these children altogether during your first day after
the day your radionuclide therapy was administered.
F Unless you work alone (for example, driving a truck), do
not return to work until 1 day after the day your radionu-
clide therapy was administered.
F Do not sleep in the same bed with your sleeping partner
until 7 days after the day your radionuclide therapy was
administered.
F However, if your sleeping partner is pregnant, do not sleep
in the same bed with your sleeping partner until 24 days
after the day your radionuclide therapy was administered.
This requires that you avoid contact with your pregnant
sleeping partner altogether during your first day after
the day your radionuclide therapy was administered.

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EXAMPLE 1: INSTRUCTION SHEETS / 167

Patient: Patient, John Q.


MRN: 111-11-111

In addition, the following precautions should be observed


until 1 day after the administration of your radiopharma-
ceutical therapy.

• To the extent that is reasonable, generally try to remain as


far away from individuals around you as possible.
• After using the toilet, flush twice and, as usual, wash your
hands. If possible, use paper towels to dry your hands and
dispose the paper toweling in the trash.
• You should otherwise observe good personal hygiene and
may shower, bathe, shave, etc. as you normally would, rins-
ing the shower stall, tub or sink thoroughly after use.
• Wipe up any spills of urine, saliva and/or mucus with
tissues or a small amount of disposable (i.e., flushable)
paper toweling, and dispose of the tissue or toweling down
the toilet.
• Use nondisposable plates, bowls, spoons, knives, forks and
cups. If possible, you should wash plates, bowls, spoons,
knives, forks and cups which you use, using a separate
sponge or wash cloth from that used by the rest of your
household. Rinse the sink thoroughly after use, wipe the
fixtures with paper towels, and dispose of the paper towel-
ing in the trash.
• If you use a dishwasher, wash your plates, bowls, spoons,
knives, forks and cups separately from those of the rest of
your household.
• Use the same set of plates, bowls, spoons, knives and forks
for 1 day after your radionuclide therapy.
• Store and launder your soiled/used clothing and bed linens
separately from those of the rest of your household, running
the rinse cycle two times at the completion of machine laun-
dering.
• Do not share food or drinks with anyone.
• After using the telephone, wipe the receiver (especially the
mouth piece) with paper towels, and dispose the paper tow-
eling in the trash.

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168 / APPENDIX B

Signature Section (example release form)

I have read this form and all of my questions have been


answered. By signing below, I acknowledge that I have read and
accept all of the information above.

Signature of patient or personal representative

Print name of patient or personal representative

Date

Relation of personal representative to patient

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B.2 EXAMPLE 2: HYPERTHYROIDISM / 169

B.2 Example 2: Hyperthyroidism

In Example 2, a hyperthyroid (Graves disease) patient was


treated with an administered activity of 370 MBq (10 mCi) of 131I
as sodium iodide. Based on published kinetic data for 131I sodium
iodide administered to such patients as well as data from the 24 h
thyroid uptake measurement for a 370 kBq (10 μCi) pretherapy
tracer administered to this patient, a bi-phasic (bi-exponential)
total-body clearance was projected, with elimination of 60 and 40 %
of the administered activity with effective half-lives of 0.32 and 7 d,
respectively, yielding an 131I residence time of 4.31 d (103 h). In
addition, survey meter measurements immediately following the
therapeutic administration yielded exposure rates of 2.4 and
24 mR h–1 at 1 and 0.3 m, respectively.
Accordingly, because all of the Column 1 values in the spread-
sheet are <5 mSv, this patient can be released on the same day the
treatment was administered, because all of these values were actu-
ally <1 mSv, the patient need not avoid normal social interactions
with children or pregnant women. However, the patient should
avoid holding small children for >10 min d–1 for 24 d after being
treated; necessitated by the fact that the values in the “1 d” subcol-
umn in Column 6 do not decrease to <1 mSv until after day 24 post-
treatment.
Because all of the Column 4 values are <1 mSv, the patient can
return to work immediately. Likewise, subject to the other dose
restrictions, general radiation precautions at home are not actually
required. Nonetheless, it would be prudent to advise the patient to
observe such precautions for at least the first day post-treatment.
On the other hand, the patient should not sleep in the same bed
with a sleeping partner until 6 d after treatment, as the values
in the “0 d” subcolumn in Column 3 do not decrease to <5 mSv
(500 mrem) until day five post-treatment. However, if the patient's
sleeping partner is pregnant, her dose limit is lowered to 1 mSv and
the patient should, therefore, not sleep in the same bed until 29 d
after treatment, as the values in the “0 d” subcolumn in Column 3
do not decrease to <1 mSv until after 29 d post-treatment.
The spreadsheet and instructions for this patient are on the fol-
lowing five pages (Zanzonico et al., 2000).

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170 / APPENDIX B

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B.2 EXAMPLE 2: HYPERTHYROIDISM / 171

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172 / APPENDIX B

Example 2: Instruction Sheets

Radiation Safety Precautions for


Radiopharmaceutical Therapy Patients

Note: Please carefully read and follow the instructions in this


document.

If you or your health care provider have any questions or con-


cerns regarding the radionuclide therapy you have received, please
contact:
Dr. J. Smith
Nuclear Medicine Attending Physician
at (111) 222-3333
Telephone Number
or 0000
Emergency or Pager Telephone Number

Patient Jane Q. Patient , Medical Record Number 222-22-222 ,


received a therapeutic dose of 370 MBq (10 mCi) of Iodine-131
Sodium Iodide at General Hospital on January 1, 2000 at
9:00 am and should observe the following radiation safety precau-
tions at home as follows.

F Avoid close contact [less than 1 meter (3 feet) away from]


with pregnant women and children until 0 day after the
administration of the radionuclide therapy; that is, there
are no restrictions on such activity.
F However, do not actually hold or embrace children for
more than 10 minutes a day until 24 days after the
administration of the radionuclide therapy.
F Do not return to work until 0 day after the administra-
tion of the radionuclide therapy; that is, you may return to
work immediately.
F Do not sleep in the same bed with your sleeping partner
until 5 days after the administration of the radionuclide
therapy.
F However, if your sleeping partner is pregnant, do not sleep
in the same bed with your sleeping partner until 29 days
after the administration of the radionuclide therapy.

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EXAMPLE 2: INSTRUCTION SHEETS / 173

Patient: Patient, Jane Q.


MRN: 222-22-222

In addition, the following precautions should be observed


until 1 day after the administration of your radiopharma-
ceutical therapy.

• To the extent that is reasonable, generally try to remain as


far away from individuals around you as possible.
• After using the toilet, flush twice and, as usual, wash your
hands. If possible, use paper towels to dry your hands and
dispose the paper toweling in the trash.
• You should otherwise observe good personal hygiene and
may shower, bathe, shave, etc. as you normally would, rins-
ing the shower stall, tub or sink thoroughly after use.
• Wipe up any spills of urine, saliva and/or mucus with
tissues or a small amount of disposable (i.e., flushable)
paper toweling, and dispose of the tissue or toweling down
the toilet.
• Use nondisposable plates, bowls, spoons, knives, forks and
cups. If possible, you should wash plates, bowls, spoons,
knives, forks and cups which you use, using a separate
sponge or wash cloth from that used by the rest of your
household. Rinse the sink thoroughly after use, wipe the
fixtures with paper towels, and dispose of the paper towel-
ing in the trash.
• If you use a dishwasher, wash your plates, bowls, spoons,
knives, forks and cups separately from those of the rest of
your household.
• Use the same set of plates, bowls, spoons, knives and forks
for 1 day after your radionuclide therapy.
• Store and launder your soiled/used clothing and bed linens
separately from those of the rest of your household, running
the rinse cycle two times at the completion of machine laun-
dering.
• Do not share food or drinks with anyone.
• After using the telephone, wipe the receiver (especially the
mouth piece) with paper towels, and dispose the paper tow-
eling in the trash.

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174 / APPENDIX B

Signature Section (example release form)

I have read this form and all of my questions have been


answered. By signing below, I acknowledge that I have read and
accept all of the information above.

Signature of patient or personal representative

Print name of patient or personal representative

Date

Relation of personal representative to patient

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B.3 EXAMPLE 3: METASTATIC CARCINOID CANCER / 175

B.3 Example 3: Metastatic Carcinoid Cancer

In Example 3, a patient with widely metastatic carcinoid cancer


was treated with an administered activity of 3.14 GBq (85 mCi) of
111
In-DTPA-D-Phe1-Octreotide. Based on kinetic measurements
of a pretherapy administration of a 203.5 MBq (5.5 mCi) 111In-
DTPA-D-Phe1-Octreotide tracer, this patient was found to exhibit
a bi-phasic (bi-exponential) total-body clearance, eliminating 70
and 30 % of the administered activity with effective half-lives
of 0.30 and 2.83 d, respectively, yielding an 111In residence time of
1.52 d or 36.6 h. In addition, survey meter measurements immedi-
ately following the therapy administration yielded exposure rates
of 10 and 113 mR h–1 at 1 and 0.3 m, respectively.
Accordingly, because all of the Column 1 values in the spread-
sheet are <5 mSv, this patient can be released on the same day of
treatment and, because all of these values were actually <1 mSv,
the patient need not avoid normal social interactions with children
or pregnant women. However, the patient should avoid holding
small children for >10 min d–1 for 18 d after being treated; necessi-
tated by the fact that the values in the “1 d” subcolumn in Column 6
do not decrease to <1 mSv until after day 18 post-treatment.
As indicated in the other subcolumns in Column 6, this “child-
avoidance” period can be shortened considerably (to as short as
10 d) if the patient avoided children altogether for several days
immediately post-treatment.
Because all of the Column 4 values after the first day post-
treatment are <1 mSv, the patient can return to work on day two
post-treatment. Likewise, subject to the other dose restrictions,
general radiation precautions at home are not actually required at
all. Nonetheless, it would be prudent to advise the patient to
observe such precautions for at least the first day after post-treat-
ment. On the other hand, the patient should not sleep in the same
bed with a sleeping partner until 5 d after treatment, as the values
in the “0 d” subcolumn in Column 3 do not decrease to <5 mSv until
day four post-treatment. However, if the patient's sleeping partner
is pregnant, her dose limit is lowered to 1 mSv and the patient
should, therefore, not sleep in the same bed until 21 d after treat-
ment, as the values in the “0 d” subcolumn in Column 3 do not
decrease to <1 mSv until after 21 d post-treatment. As indicated in
the other subcolumns in Column 3, this period can be shortened
considerably if the patient avoided the pregnant sleeping partner
altogether for the first several days post-treatment.
The spreadsheet and instructions for this patient are on the fol-
lowing five pages (Zanzonico et al., 2000).

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176 / APPENDIX B

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B.3 EXAMPLE 3: METASTATIC CARCINOID CANCER / 177

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178 / APPENDIX B

Example 3: Instruction Sheets


Radiation Safety Precautions for
Radiopharmaceutical Therapy Patients

Note: Please carefully read and follow the instructions in this


document.
If you or your health care provider have any questions or con-
cerns regarding the radionuclide therapy you have received, please
contact:

Dr. J. Smith
Nuclear Medicine Attending Physician
at (111) 222-3333
Telephone Number
or 0000
Emergency or Pager Telephone Number

Patient Joe Q. Patient , Medical Record Number 333-33-333 ,


received a therapeutic dose of 3.145 MBq (85 mCi) of Indium-111-
DTPA-D-Phel_Octreotide at General Hospital on January 1, 2001
at 9:00 am and should observe the following radiation safety pre-
cautions at home as follows.

F Avoid close contact [less than 1 meter (3 feet) away from]


with pregnant women and children until 0 days after the
administration of the radionuclide therapy; that is, there
are no restrictions on such activity.
F However, do not actually hold or embrace children for
more than 10 minutes a day until 18 days after the
administration of the radionuclide therapy.
F Do not return to work until 1 day after the administra-
tion of the radionuclide therapy.
F Do not sleep in the same bed with your sleeping partner
until 4 days after the administration of the radionuclide
therapy.
F However, if your sleeping partner is pregnant, do not sleep
in the same bed with your sleeping partner until 21 days
after the administration of the radionuclide therapy.

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EXAMPLE 3: INSTRUCTION SHEETS / 179

Patient: Patient, Joe Q.


MRN: 333-33-333

In addition, the following precautions should be observed


until 1 day after the administration of your radiopharma-
ceutical therapy.

• To the extent that is reasonable, generally try to remain as


far away from individuals around you as possible.
• After using the toilet, flush twice and, as usual, wash your
hands. If possible, use paper towels to dry your hands and
dispose the paper toweling in the trash.
• You should otherwise observe good personal hygiene and
may shower, bathe, shave, etc. as you normally would, rins-
ing the shower stall, tub or sink thoroughly after use.
• Wipe up any spills of urine, saliva and/or mucus with
tissues or a small amount of disposable (i.e., flushable)
paper toweling, and dispose of the tissue or toweling down
the toilet.
• Use nondisposable plates, bowls, spoons, knives, forks and
cups. If possible, you should wash plates, bowls, spoons,
knives, forks and cups which you use, using a separate
sponge or wash cloth from that used by the rest of your
household. Rinse the sink thoroughly after use, wipe the
fixtures with paper towels, and dispose of the paper towel-
ing in the trash.
• If you use a dishwasher, wash your plates, bowls, spoons,
knives, forks and cups separately from those of the rest of
your household.
• Use the same set of plates, bowls, spoons, knives and forks
for 1 day after your radionuclide therapy.
• Store and launder your soiled/used clothing and bed linens
separately from those of the rest of your household, running
the rinse cycle two times at the completion of machine laun-
dering.
• Do not share food or drinks with anyone.
• After using the telephone, wipe the receiver (especially the
mouth piece) with paper towels, and dispose the paper tow-
eling in the trash.

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180 / APPENDIX B

Signature Section (example release form)

I have read this form and all of my questions have been


answered. By signing below, I acknowledge that I have read and
accept all of the information above.

Signature of patient or personal representative

Print name of patient or personal representative

Date

Relation of personal representative to patient

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Appendix C

Quality Assurance for


High Dose-Rate
Brachytherapy
Applications

The items presented in this Appendix are intended to provide a


template that allows each institution to develop its own QA
program. This Appendix cannot be all-inclusive and procedures
may differ significantly among the various commercial devices
available. As such, these recommendations should be viewed as
supplemental to QA recommendations from the manufacturers of
the various devices. It may also be useful to review the recommen-
dations of other voluntary organizations such as AAPM (Kubo
et al., 1998; Kutcher et al., 1994; Nath et al., 1997; Williamson
et al., 1994).
Certain QC checks should be performed at the start of the treat-
ment day or within 24 h of the start of treatment. Other checks
should be done immediately before or after treatment.

C.1 Treatment-Preparation Checks

Within 24 h of the start of treatment or at the start of each treat-


ment day, the following items should be checked:

• operating condition of reusable applicator systems;


• correct functioning and identity of single-use applicators;
• procedure room preparations;
• correct functioning of remote afterloader;
• operation of treatment-room status indicators and alarm
indicator;
• availability of afterloader manual;
• presence and correct functioning of survey instrument;

181

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182 / APPENDIX C

• functional status of audio/visual communication systems;


• functional status of independent area monitor;
• availability of emergency procedure kit;
• redundant check of assumed source strength;
• spot check of positional accuracy;
• functioning of interlocks at room entrance;
• timer accuracy;
• correct date and time in unit’s computer; and
• availability and condition of transfer tubes.

C.2 Applicator Checks

The following items or systems should be checked and recorded


for each treatment:

• applicator identity should be verified and recorded;


• anatomical data needed to identify active dwell positions
have been obtained and recorded;
• geometric limitations of the applicator are observed; and
• applicator is correctly assembled.

C.3 Implant Localization and Imaging

Once the applicator has been placed in the patient, imaging of


the applicator in the treatment position can be performed. The fol-
lowing data checks should be performed:

• applicator(s) is (are) numbered and correctly recorded on


the implant diagram;
• multiple applicators, if present, can be distinguished radio-
graphically and correlated with an external numbering
system;
• data needed to calculate afterloader-position programming
parameters have been measured, recorded and verified;
• imaging parameters (source-film distance, angle, etc.) are
correctly recorded; and
• patient name, medical record number, or other identifiers
have been recorded on films and in digital systems.

C.4 Treatment Prescription

The treatment prescription should be available at the treatment


console before and during treatment. The following items should be
present and reviewed:

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C.6 PRETREATMENT REVIEW / 183

• radiation oncologist has signed and reviewed films or


images;
• radiation oncologist has signed the treatment prescription;
• radiation oncologist and radiation-oncology physicist have
agreed on treatment-planning constraints, dose-specification
criteria, and optimization endpoints; and
• radiation oncologist and radiation-oncology physicist have
both signed the treatment plan.

C.5 Treatment Planning

The following items should be checked before treatment begins:

• programming parameters required by the treatment unit


are calculated and independently verified;
• dosimetrist and medical physicist review the planning pro-
cedure to be used and agree on reconstruction, optimization
and dose-specification procedures to be used;
• dosimetrist or medical physicist verifies patient name on
films, prescription and other data, and confirms that the
date, time and source strength displayed on planning sys-
tem. Dosimetrist or medical physicist verifies prescribed
dose per fraction against the written prescription; and
• dosimetrist or medical physicist verifies the film orienta-
tions, distances, magnifications and gantry angles against
requirements for selected reconstruction algorithm.

C.6 Pretreatment Review

This Section is intended to identify the key items to be checked


by members of the treatment team. There will be some overlap
among these responsibilities, but the responsibility of each person
should be clear.
The radiation-oncology physicist should review:

• treatment plan and all associated documentation;


• accuracy of critical input data including prescribed dose and
source strength;
• positional accuracy;
• accuracy of implant reconstruction;
• independent check of dwell-time calculation accuracy;
• consistency of patient name and identifiers on all documen-
tation; and
• completion of QA measurements.

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184 / APPENDIX C

The radiation oncologist should review:

• clinical adequacy of treatment plan and consistency with


written prescription;
• target-volume coverage and doses to critical structures; and
• completion of physics checks.

C.7 Patient Setup

The treatment-unit operator, typically a radiation therapist,


will place the patient in the treatment position and program treat-
ment parameters verifying the following:

• dose per fraction in treatment plan and prescription agree.


The therapist will compare the total dose and number of
fractions against treatment(s) previously received;
• agreement between current source strength (i.e., decayed
source strength) on treatment plan and the data on the
remote afterloader;
• completed prescription is present and signed by both the
radiation oncologist and radiation-oncology physicist;
• correct length transfer tubes are being used;
• applicator number and channel number correspond;
• dwell-times and positional settings recorded and displayed
by afterloader match the treatment plan;
• identity of patient is verified and matched against the pre-
scription; and
• dose per fraction in the treatment plan is matched against
the prescription and the daily treatment record.

C.8 Setup Accuracy

The following additional checks apply to the role of the radiation


oncologist and radiation physicist. They should ensure that the:

• applicator number and channel number correspond;


• applicator position is checked against measurements made
in the operating room and against any reference (fiducial)
marks; and
• afterloading programming parameters are verified.

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C.10 POST-TREATMENT CHECKS / 185

C.9 Treatment

While treatment is in progress, the radiation oncologist (or


physician designate), the radiation-oncology physicist, and the
radiation-therapist operator shall be available during the entire
treatment.

C.10 Post-Treatment Checks

At the end of the treatment session and before the patient is


released, the following checks should be performed:

• patient and personnel safety


- console indicates source is retracted and treatment is
complete;
- area monitor operation is checked before entering the
treatment room and indicates that source is retracted;
- treatment room is checked with a survey meter to con-
firm complete retraction of the source(s);
- HDR device is shut down and secured after the patient
is removed; and
- patient is checked with a survey meter after removal
from the treatment room to verify that there are no
sources present.
• treatment accuracy and chart order
- treatment is properly recorded;
- total dwell-time administered by the device agrees with
the calculation; and
- all forms and checklists are complete and properly filed.

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Appendix D

Shielding for High


Dose-Rate
Brachytherapy
Facilities

This Appendix supplements the information presented in Sec-


tion 5 of this Report. The shielding design approach and the appli-
cable values for shielding design goals (P) recommended for
medical-radiation facilities in NCRP Report No. 147 (NCRP, 2004a)
and NCRP Report No. 151 (NCRP, 2005) are also recommended
for HDR brachytherapy facilities. The reader is referred particu-
larly to NCRP Report No. 147 (NCRP, 2004a) for more detail when
the radiation source is limited to low-LET radiation and NCRP
Report No. 151 (NCRP, 2005) for considerably more detail on
shielding design for other types of radiotherapy facilities, including
when high-LET radiation is present.
This Appendix addresses the planning and design of new HDR
brachytherapy facilities or the remodeling of existing HDR brachy-
therapy facilities. HDR brachytherapy facilities designed before
the publication of this Report and meeting the requirements of
NCRP Report No. 49 (NCRP, 1976) need not be reevaluated (NCRP,
1993b) unless there are changes in a facility’s design or use. New
equipment, significant changes in the use of existing equipment, or
other changes that may have an impact on radiation protection of
the staff or members of the public require an evaluation by a qual-
ified expert. This Appendix does not attempt to summarize the reg-
ulatory or licensing requirements of the various authorities that
may have jurisdiction over matters addressed in this Appendix.
It is expected that the qualified expert will be fully aware of
these matters and account for them in the final shielding design.
While specific recommendations on shielding design methods are

186

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D.1 GENERAL CONCEPTS / 187

presented, alternate methods may prove equally satisfactory in


providing adequate radiation protection. The final assessment of
the adequacy of the design and construction of protective shielding
can only be based on the post-construction radiation survey per-
formed by a qualified expert. If the survey indicates shielding inad-
equacy, remediation by the addition of shielding or modifications of
equipment and procedures shall be made. Specific shielding consid-
erations for radiopharmaceutical therapy, other types of brachy-
therapy, and associated equipment and facilities are discussed
throughout Section 5.
The term “qualified expert” as used in this Report and Appendix
is defined as a medical physicist or health physicist who is compe-
tent to design radiation shielding in radiotherapy facilities, and
who is certified by the American Board of Radiology, American
Board of Medical Physics, American Board of Health Physics, or
Canadian College of Physicists in Medicine. Radiation shielding
shall be designed by a qualified expert to ensure that the required
degree of protection is achieved. The qualified expert should be con-
sulted during the early planning stages since the shielding require-
ments may affect the choice of location and type of building
construction. The qualified expert should be provided with all per-
tinent information regarding the proposed radiation equipment
and its use, type of building construction, and occupancy of nearby
areas. It may also be necessary to submit the final shielding draw-
ings and specifications to pertinent regulatory agencies for review
prior to construction.

D.1 General Concepts

The exposure rate from a point radiation source varies inversely


as the square of the distance from the source. The exposure time
involves both the time that the sealed radioactive source is present
outside of a self-shielded housing and the fraction of the treatment
time during which a person is present within the radiation field.
When the radiation source is brought outside of the shielded hous-
ing, sometimes referred to as the “safe,” the radiation field will be
essentially isotropic. Therefore, the term, use factor (U) (NCRP,
2005), which is typically defined as the fraction of time that a radi-
ation beam is directed toward a shielding barrier, will always
be unity for shielding calculations for HDR brachytherapy units.
There will be no secondary barriers since all barriers will be
exposed to the source as well as to radiation scattered from the
patient and objects in the treatment room.

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188 / APPENDIX D

D.1.1 Occupancy Factor

The occupancy factor (T) for an area is the average fraction of


time that the maximally exposed individual is present while the
sealed source is in use and outside of its self-shielded housing. For
any particular individual, the occupancy factor is the fraction of the
working hours in the week that this individual would occupy
the shielded area, averaged over the year. For example, an uncon-
trolled area adjacent to a treatment room having an assigned occu-
pancy factor of 1/40 would imply that the maximally exposed
individual would spend an average of 1 h week–1 in that area every
workweek for a year.
The occupancy factor for an area is not the fraction of time that
it is occupied by any persons, but rather it is the fraction of the time
during which it is occupied by the single person who spends the
most time there. Thus, a waiting room might be occupied at all
times during the working day, but have a very-low occupancy factor
since no single person is likely to spend >50 h y–1 in any given wait-
ing room. However, if there were to be a receptionist or administra-
tive personnel continuously present in the waiting area, the
occupancy factor might approach one.
Occupancy factors in uncontrolled areas will rarely be deter-
mined by visitors to the facility or its environs who might be there
only for a small fraction of a year. The maximally exposed individ-
ual will normally be an employee of the facility. The occupancy fac-
tor for controlled areas is usually assigned a value of unity. As
mentioned in Section 5 of this Report, Table B.1 of NCRP Report
No. 151 (NCRP, 2005) lists suggested occupancy factors for use as
a guide in planning shielding.

D.1.2 Assumptions

The specified shielding design will be conservatively safe


because of the nature of the assumptions made in the shielding
design such as:

• attenuation of the radiation within the patient is neglected.


The patient typically attenuates the emitted radiation by
30 % or more;
• calculations of recommended barrier thickness often assume
perpendicular incidence of the radiation. If the incidence
were not perpendicular, the effect would vary in magnitude,
but would always result in a reduction in the transmission
through the barrier for photons that have nonperpendicular

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D.1 GENERAL CONCEPTS / 189

incidence. This reduction is due to both the increased thick-


ness of the barrier at various angles as well as the resulting
increased distance to the barrier;
• minimum distance to the occupied area from a shielded wall
is assumed to be 0.3 m. This value is typically a conserva-
tively safe estimate for most walls and especially for doors.
If a distance >0.3 m were assumed, the effect would vary,
but radiation levels decrease with increasing distance; and
• recommended occupancy factors for uncontrolled areas are
typically conservatively high. For example, very few people
spend 100 % of their time in their office. If more realistic
occupancy factors were to be used, the effect on a calculation
would vary in magnitude, but would generally result in a
reduction in the amount of exposure received by an individ-
ual located in an uncontrolled area.

D.1.3 Workload

The units for workload (W) in NCRP Report No. 151 (NCRP, 2005)
are Gy week–1 at 1 m and conversion to a workload Wn at a distance dn
other than 1 m would be given by Wn = W (1 m)2 / (dn)2, a typical inverse
square-law calculation. For linear accelerators, the value for W is usu-
ally specified as the absorbed dose from photons delivered to the
isocenter (i.e., the fixed location around which the machine gantry
rotates), in a week, and is selected for each accelerator based on its
projected use. A similar concept would apply to HDR brachyther-
apy units within shielded rooms.

Example: A typical air-kerma rate for an 192Ir HDR unit with a


source loading of 370 GBq (10 Ci) would be ~0.039 Gy h–1 at 1 m
which roughly equates to an absorbed-dose rate of 0.043 Gy h–1 at
1 m. This information and the number of patients treated per day,
treatment time per patient, and number of treatment days per
week of operation are used to determine the workload.
For a treatment load of four patients per day with an average
treatment time of 20 min per patient, the treatment time per day
would be 80 min. Assuming a treatment schedule of 5 d week–1, the
total treatment time per week would be 400 min or ~6.7 h week–1.
Multiplying this value by the absorbed-dose rate at 1 m,
0.043 Gy h–1, yields a workload of 0.3 Gy week–1.
Workload estimates should also include an estimate of the
absorbed dose delivered during QC checks, calibrations, or other
physics measurements. If the calibration, QC checks, or other phys-
ics measurements are made at distances or locations other than the

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190 / APPENDIX D

treatment distance and location, a separate assessment should be


made for the distance and occupancy factors that may apply.
If the HDR unit were to be located within another treatment
room (e.g., a linear accelerator room) that is also used for patient
treatment, the number of treatment hours available for HDR treat-
ments may be limited by the schedule for the other treatment
modalities. The required shielding for the treatment room will be
determined by the total workload for all the radiotherapy equip-
ment located in the room.

D.1.4 Location of the Treatment

The location of the treatment table or couch within the treat-


ment room will be used to determine the distance from the source
to the shielded area. There are a number of potential locations for
a treatment couch, including the following:

• when the HDR unit is located within a treatment room des-


ignated for other types of radiation treatments (e.g., an HDR
unit within a linear accelerator vault) the accelerator treat-
ment table within the room may serve as the HDR
treatment couch. Typically, this requires adding devices to
the treatment couch (e.g., stirrups) so that the patient can
be positioned for treatment;
• when the HDR unit is located within a treatment room as
above, a separate treatment table may be stored with the
HDR unit. This table would only be used for HDR treat-
ments. When in use, the treatment table would need to be
positioned within the field of view of cameras located within
the treatment room. Typically, at least two cameras are
present within the treatment room, one near-field and one
far-field camera, which allow the patient to be viewed dur-
ing treatment; and
• a separate facility may be available for HDR treatment and
this facility may use a standard examining table equipped
for urological or gynecological treatment.

In any of the examples noted above, the distance from the source
to the shielded area may vary. However, it is important to define
clearly the limits of positioning and the distances to the areas to be
protected.

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D.2 CONSTRUCTION INSPECTION / 191

D.1.5 Source Parameter

Currently available commercial HDR units use sources of 192Ir


with activities varying between 370 GBq (10 Ci) and 444 GBq
(12 Ci). Several manufacturers are hoping to increase the available
sealed source activity to 555 GBq (15 Ci). Various authors have
explored the use of 169Yb for brachytherapy and more recently the
use of 170Tm has also been proposed (Das et al., 1997; Granero
et al., 2006; Williamson, 1996). These radionuclides combine the
possibility of high specific activity with the emission of low-energy
photons. As compared to 192Ir, the shielding for the lower
energy radionuclides will be reduced in thickness. Table D.1 lists
the half-value layers (HVL) and tenth-value layers (TVL) for 192Ir
and 169Yb. The first TVL and equilibrium tenth-value layers (TVLe)
values are used to account for the changes in the radiation spec-
trum that occur as the radiation penetrates the barrier. For the
values given in Table D.1, lead density was taken to be 11.36 g cm–3
and concrete density was taken to be 2.3 g cm–3.
Two literature references have recently presented the results
of Monte-Carlo simulations for various parameters used in shield-
ing for HDR units (Granero et al., 2006; Lymperopoulou et al.,
2006). Figures D.1 and D.2 present transmission curves in lead and
concrete for three HDR sealed sources, one that is in use currently
and the other two that have the potential for future use in HDR
brachytherapy.

D.2 Construction Inspection

It is recommended that a qualified expert carry out physical


inspections of the facility during construction. The inspections
should include, at a minimum, an evaluation of the following items:

• thickness and density of concrete, if used;


• thickness of lead shielding, if used;
• heating, ventilation and air conditioning, and shielding baf-
fles, as necessary;
• location and size of conduit(s) or pipe used for electrical
cables, including cables for control consoles and machine
operation, plumbing or other penetrations of the shielding;
and
• verification that the shielding design has been followed.

It is often impractical to make an overall experimental determi-


nation of the adequacy of the shielding prior to the completion of

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192 / APPENDIX D

TABLE D.1—Values for lead and concrete for HVL, HVLe , TVL, and
TVLe for 192Ir and 169Yb (Lymperopoulou, 2006).

First HVL HVLe First TVL TVLe

Lead thickness (mm)


192
Ir 2.8 5.7 11.0 18.7

3a 6b 12a 20b
169
Yb 0.25 1.6 1.8 5.3

0.23c — 2a —

Concrete thickness (cm)


192
Ir 6.5 4.2 17.6 14.1
b
— 3 — 4.7b

3.2 3.4 10.6 11.4


c c
2.7 — 10.4 —
a
Values reported in Lymperopoulou et al. (2006) and taken from Delacroix
(1998).
bValues reported in Lymperopoulou et al. (2006) and taken from NCRP (1976).
c
Values reported in Lymperopoulou et al. (2006) and taken from Granero
(2006). Lead density was taken to be 11.36 g cm–3 and concrete density was
taken to be 2.3 g cm–3.

the building construction and the installation of the radiotherapy


equipment. Periodic inspections during the entire construction
period should be performed. Sometimes properly constructed
shielding is compromised by subsequent changes that are made to
install ducts, recessed boxes, or other hardware. These alterations
can be made to walls, ceilings or floors. Hence, there should be peri-
odic checks of the continued validity of shielding assumptions and
the integrity of the barriers.
The shielding of the treatment room shall be constructed so that
the shielding is not compromised by joints, by openings for ducts,
pipes or other objects passing through the barriers, or by conduits,
service boxes, or other structural elements embedded in the shield-
ing barriers. Other aspects of facility design, such as interlocks,
warning signs, warning lights, electrical safety, and room lighting
are discussed briefly in NCRP Report No. 151 and are discussed
in more detail in NCRP Report No. 102 (NCRP, 1989; 2005). A

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D.2 CONSTRUCTION INSPECTION / 193

192
Fig. D.1. Transmission as a function of lead thickness for Ir,
169
Yb, and 170Tm (lead density is taken as 11.36 g cm–3).

summary document outlining the results of the construction


inspection shall be prepared by the qualified expert and forwarded,
as appropriate, to the owner of the facility, the architectural firm
involved in the construction and any governing regulatory agency,
as necessary. Any items of noncompliance shall be clearly indicated
and recommendations for remediation should be made.

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194 / APPENDIX D

192
Fig. D.2. Transmission as a function of concrete thickness for Ir,
169
Yb, and 170Tm (concrete density is taken as 2.35 g cm–3).

D.3 Performance Assessment

After construction, a performance assessment (i.e., a radiation


survey), including measurements in controlled and uncontrolled
areas, shall be made by a qualified expert to confirm that the
shielding provided will achieve the applicable shielding design

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D.4 DOCUMENTATION REQUIREMENTS / 195

goals for controlled and uncontrolled areas. This performance


assessment is an independent check that the assumptions used in
the shielding design are conservatively safe. For a discussion of
shielding evaluations [see Section 6.4 of NCRP Report No. 151
(NCRP, 2005)].

D.4 Documentation Requirements

The following documentation shall be maintained on a perma-


nent basis by the owner of the facility:

• shielding design report, including assumptions and specifi-


cations;
• construction, or preferably as-built, documents showing
location and amounts of shielding material installed;
• post-construction survey reports;
• information regarding remediation, if any were required;
and
• any subsequent evaluations of the room shielding relative to
changes (e.g., in utilization) that have been made or are
under consideration.

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Glossary

absorbed dose (D): Quotient of dε by dm, where dε is the mean energy


imparted by ionizing radiation to matter in a volume element and dm
is the mass of matter in that volume element: D = dε /dm. For pur-
poses of radiation protection and assessing dose or risk to humans in
general terms, the quantity normally calculated is the mean absorbed
dose in an organ or tissue (T): DT = ε T /mT, where ε is the total energy
imparted in an organ or tissue of mass mT. The SI unit of absorbed
dose is the joule per kilogram (J kg–1), and its special name is the gray
(Gy). In conventional units often used by federal and state agencies,
absorbed dose is given in rad; 1 rad = 0.01 Gy.
activity (A): Rate of transformation (disintegration or decay) of radioac-
tive material. The SI unit of activity is the reciprocal second (s–1), and
its special name is the becquerel (Bq). In conventional units often used
by federal and state agencies, activity is given in curies (Ci); 1 Ci =
3.7 × 1010 Bq.
administered activity (AA): The amount, in terms of activity, of radio-
active source material given to a patient during a diagnostic or thera-
peutic procedure. (Although the term “dose” is often used in practice in
referring to the administered activity, the latter quantity is not the
same as absorbed dose.)
air kerma (kerma) (kinetic energy released per unit of mass) (K):
The quotient of the sum of the initial kinetic energies of all the
charged particles liberated by uncharged particles in matter divided
by the mass of the matter into which the particles are released and is
given the special name gray (Gy). 1 Gy = 1 J kg–1. In the event that the
matter is air, kerma is often referred to as air kerma.
air-kerma strength (SK): Product of the air-kerma rate and the square
of the distance. The units of air-kerma strength are µGy m2 h–1 or cGy
cm2 h–1.
as low as reasonably achievable (ALARA): Principle of radiation pro-
tection that calls for every reasonable effort to maintain radiation
exposures as far below specified limits as is practical, taking into
account cost-benefit and any other societal concerns.
becquerel (Bq): SI special name for the unit of activity. 1 Bq equals one
disintegration per second. 37 MBq (megabecquerels) = 1 mCi
(millicurie) (see curie).
brachytherapy: Method of radiation therapy in which an encapsulated
source is utilized to deliver gamma or beta radiation at a distance up
to a few centimeters either by surface, intracavitary or interstitial
application.

196

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GLOSSARY / 197

chart: A patient’s medical record or treatment folder in written or elec-


tronic (computerized) format that is the permanent institutional docu-
ment in a medical facility and that fully describes the medical history
and care of the patient.
contamination: Radioactive material suspended in air or deposited
in any area or on any surface where its presence is unwanted or
unexpected.
controlled area: Limited-access area in which the occupational exposure
of personnel to radiation is under the supervision of an individual in
charge of radiation protection. This definition implies that access,
occupancy and working conditions are controlled for purposes of radia-
tion protection.
curie (Ci): Conventional special name for the unit of activity equal to
3.70 × 1010 becquerels (or disintegrations per second) (see becquerel).
deterministic effects: Detrimental health effects for which the severity
varies with the dose of radiation (or other toxic substance), and for
which a threshold usually exists.
dose equivalent (H): Absorbed dose (D) at a point in tissue weighted by
quality factor (Q) for type and energy of the radiation causing the
dose: H = D × Q. For purposes of radiation protection and assessing
health risks in general terms, and especially prior to introduction of
the equivalent dose and as used by federal and state agencies, dose
equivalent often refers to mean absorbed dose in an organ or tissue (T)
weighted by average quality factor ( Q ) for the particular type of radia-
tion: HT = DT × Q . The SI unit of dose equivalent is the joule per kilo-
gram (J kg –1), and its special name is the sievert (Sv). In conventional
units often used by federal and state agencies, dose equivalent is given
in rem; 1 rem = 0.01 Sv
dose limit (Elimit): Limit on effective dose that is applied for exposure to
individuals in order to prevent the occurrence of radiation induced
deterministic effects and to limit the probability of radiation-related
stochastic effects to an acceptable level.
effective dose (E): Sum over specified organs and tissues (T) of mean
dose equivalent in each tissue weighted by tissue weighting fac-
tor (wT):. It is given by the expression:

E = Σ wT HT , (G.1)

where HT is the equivalent dose in tissue or organ T and wT is the tis-


sue weighting factor for tissue or organ T. The unit for E and HT is
joule per kilogram (J kg –1) with the special name of sievert (Sv). 1 Sv =
1 J kg –1 (supersedes effective dose equivalent).
equivalent dose (HT): Mean absorbed dose in a tissue or organ weighted
by the radiation weighting factor (wR) for the type and energy of radia-
tion incident on the body. The equivalent dose in tissue or organ T is
given by the expression:

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198 / GLOSSARY

HT = Σ wR DT,R , (G.2)

where DT,R is the mean absorbed dose in the tissue or organ T due to
radiation type R. The SI unit of equivalent dose is the joule per kilo-
gram (J kg –1) with the special name sievert (Sv). 1 Sv = 1 J kg–1.
exposure (X): Most often used in a general sense meaning to be irradi-
ated. When used as the specifically defined radiation quantity,
exposure is a measure of the ionization produced in air by x or
gamma radiation. The unit of exposure is coulomb per kilogram
(C kg–1). The special unit for exposure is roentgen (R), where 1 R =
2.58 × 10–4 C kg–1.
family member: Any person who provides support and comfort to a
patient on a regular basis and is considered by the patient as a mem-
ber of their “family” whether by birth or marriage or by virtue of
a close, loving relationship.
gray (Gy): SI special name for the unit of the quantities absorbed dose
and air kerma. 1 Gy = 1 J kg–1.
half-life (T1/2): Time required to reduce spontaneously the activity of a
radionuclide to one-half of the activity originally present. Physical or
radioactive half-life refers to reduction of activity by radioactive decay;
biological half-life refers to elimination of the activity by biological
processes; and effective half-life refers to the combined action of radio-
active decay and biological elimination.
high dose rate (HDR): As used in brachytherapy, HDR refers to a type of
remote afterloader housed in a treatment room that contains a high
activity source of radiation used to deliver a therapeutic treatment to
a patient in a relatively short treatment time.
implant: A completed assembly of radioactive sealed sources with or
without applicators that is placed in a patient with therapeutic intent.
integrated reference air kerma (IRAK): Special term used in brachy-
therapy for integrated reference air kerma strength, a product of SK
and treatment time. The unit of IRAK is Gy m2.
kerma (K): (see air kerma).
low dose rate (LDR): As used in brachytherapy, LDR refers to the use of
sealed sources placed in a patient on a permanent or temporary basis
to deliver a therapeutic dose of radiation.
medical facility: A hospital, clinic or other facility that may practice
radiation therapy with sealed sources or radiopharmaceuticals and
that provides in-patient care. This definition specifically excludes the
patient’s own home.
medical health physicist: (see qualified expert).
medical physicist (medical-radiation physicist): (see qualified
expert).
member of the public: In the context of possible radiation exposure
from a radioactive patient, this term refers to any individual, not a
member of the patient’s family and not an individual exposed to radia-
tion in the course of their employment.

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GLOSSARY / 199

milligrams radium equivalent (mgRaEq): Strength of a given source


in milligrams radium equivalent is the mass in milligram of 226Ra,
encapsulated in a cylinder with wall thickness of 0.5 mm platinum-
iridium, that gives the same transverse-axis radiation output, or air-
kerma strength, as the source itself.
nuclear-medicine physician: Physician licensed to practice medicine
who is qualified by training and experience to be authorized under the
facility’s license to prescribe the administration of therapeutic
amounts of radiopharmaceuticals. Use of the term “nuclear-medicine
physician” does not require that the physician be part of a facility’s
nuclear-medicine group.
occupational exposures: Radiation exposures to individuals that are
incurred in the workplace as a result of situations that can reasonably
be regarded as being the responsibility of management (exposures
associated with medical diagnosis of or treatment for the individual
are excluded).
preloaded applications: “Hot source” brachytherapy technique that
consists of placing the radioactive sources manually or placing appli-
cators previously loaded with radioactive sources in the treatment site
during an operative procedure.
qualified expert: A medical physicist or medical health physicist, who is
competent to design radiation shielding, evaluate the results of radia-
tion dosimetry measurements, and specify radiation precautions to be
observed when administering or handling radioactive materials. The
qualified expert is a physicist certified by the American Board of Radi-
ology, American Board of Medical Physics, American Board of Health
Physics, or the Canadian College of Physicists in Medicine.
rad: Special name for the conventional unit of absorbed dose. 1 rad =
0.01 J kg–1. In the SI system of units, it is replaced by the special
name gray (Gy). 1 Gy = 100 rad.
radiation oncologist: Physician licensed to practice medicine who is
qualified by training and experience to prescribe the administration of
brachytherapy treatment. Use of the term “radiation oncologist” does
not require that this physician be part of a facility’s radiation-oncology
department or group. In certain jurisdictions, the qualifications
required under the appropriate regulatory authority may also be met
by osteopaths.
radiation safety officer (RSO): An individual who meets the applicable
regulatory requirements of training and experience to be named on a
facility’s license as the RSO. Depending on the license and complexity
of the program, the RSO may be a nuclear-medicine physician, a radi-
ologist, a radiation oncologist, a nuclear pharmacist, a medical physi-
cist, or a medical health physicist. Facilities may use alternate titles
such as radiation protection supervisor or radiation safety manager.
Throughout this Report, any reference to the RSO is intended to
include individuals designated by the RSO such as radiation safety
staff.

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200 / GLOSSARY

radiation weighting factor (wR): Dimensionless weighting factor


developed for purposes of radiation protection and assessing health
risks in general terms that accounts for relative biological effective-
ness of different types (and, in some cases, energies) of radiations in
producing stochastic effects and is used to relate mean absorbed
dose in an organ or tissue (T) to equivalent dose. The radiation
weighting factor is intended to supersede the mean quality factor ( Q )
and is defined with respect to the type and energy of the radiation
incident on the body or, in the case of sources within the body, emitted
by the source. Radiation weighting factor is independent of tissue
weighting factor (wT).
radiopharmaceutical: Radioactive substance administered to a patient
for diagnostic or therapeutic nuclear-medicine procedures. A radiop-
harmaceutical contains two parts, the radionuclide and the pharma-
ceutical (e.g., 99mTc DTPA). In some cases the two are one (e.g., 133Xe
gas).
rem: Special name for the conventional unit numerically equal to the
absorbed dose (D) in rad, modified by a quality factor (Q). 1 rem =
0.01 J kg–1. In the SI system of units, it is replaced by the special
name sievert (Sv), which is numerically equal to the absorbed dose (D)
in gray modified by a radiation weighting factor (wR). 1 Sv = 100 rem.
roentgen (R): Special name for the unit of exposure. Exposure is a spe-
cific quantity of ionization (charge) produced by the absorption of x- or
gamma-radiation energy in a specified mass of air under standard
conditions. 1 R = 2.58 × 10–4 coulomb per kilogram (C kg–1).
sievert (Sv): Special name for the SI unit of dose equivalent, equivalent
dose, and effective dose. 1 Sv = 1 J kg–1.
specific bremsstrahlung constant (Γbr): Constant that relates
the activity in a point source of beta-emitting radiation to the
bremsstrahlung exposure rate from that source. The unit of the spe-
cific bremsstrahlung constant is R cm2 mCi–1 h–1.
specific gamma-ray constant (Γγ): Constant that relates the activity
in a point source of penetrating radiation (photons) to the exposure
rate from the source. The units of the specific gamma-ray constant is
R cm2 mCi–1 h–1, equivalent to the exposure rate in air in R h–1 at 1 cm
from a 1 mCi source. The specific gamma-ray constant is unique to the
radionuclide under consideration.
stochastic effects: Adverse effects in biological organisms for which the
probability, but not the severity, is assumed to be a function of dose of
ionizing radiation (or other contaminant) without threshold.
survey meter: Instrument or device, usually portable, for monitoring
the level of radiation or of radioactive contamination in an area or
location.
tissue weighting factor (wT): Dimensionless factor that represents
ratio of the stochastic risk attributable to a specific organ or tissue (T)
to total stochastic risk attributable to all organs and tissues when
the whole body receives a uniform exposure to ionizing radiation.
When calculating effective dose equivalent, tissue weighting factor

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GLOSSARY / 201

represents the risk of fatal cancers or severe hereditary effects. When


calculating effective dose, tissue weighting factor represents total
detriment.
treatment folder: (see chart).
use factor (U) (beam direction factor): Fraction of the workload during
which the useful beam is directed at the barrier under consideration.

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Symbols and Acronyms

A activity
à cumulated activity in a patient per unit admin-
istered activity AA
AA activity administered to a patient
ALARA as low as reasonably achievable
A(t) total body activity at post-administration time
CT computed tomography
d distance
D absorbed dose
·
Dr absorbed-dose rate in a medium at distance r
DTPA diethelyene triamine pentaacetic acid
DT,R mean absorbed dose for tissue T and radiation
type R
E effective dose, summation of all HT × wT
–1
E Ka effective dose per unit air-kerma conversion
coefficient
Elimit effective dose limits for radiation protection
Ep photon energy
·
E ( r j ,t ) effective dose rate at a distance at a post-admin-
istration time
E ( rj )t → t effective dose at a distance at a post-administra-
1 2
tion time period
ERT external-beam radiotherapy
Fi zero time intercept of total body activity of expo-
nential component i
GM Geiger-Muller
H dose equivalent
HDR high dose rate
Hp(d) personal dose equivalent at a depth in tissue
HT equivalent dose to tissue organ, the summation
of all HT,R
HT,R equivalent dose, DT,R × wR
HVL half-value layer
HVLe equilibrium half-value layer

202

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SYMBOLS AND ACRONYMS / 203

IRAK integrated reference air kerma


ISO isotropic
Ka air kerma

med
( Ka ) ratio of the air kerma in the medium to that in
b air
air at distance r from the source
·
K a ( r j ,t ) air kerma rate at a distance at a post-adminis-
tration time
LDR low dose rate
LET linear energy transfer
MCPT Monte-Carlo photon transport
µ linear attenuation coefficient
μ
⎛ -------
en⎞
med
- mass-energy absorption coefficient ratio to con-
⎝ ρ ⎠ air
vert air kerma to absorbed dose in a medium
n number of exponential components required to
describe time-dependent total-body activity
P shielding design goal
PET positron-emission tomography
PET/CT positron-emission tomography combined with
computed tomography
PDR pulsed dose rate
PTA percutaneous transluminal balloon angioplasty
PTCA percutaneous transluminal coronary angio-
plasty
Q quality factor
QA quality assurance
QC quality control
r distance from the radioactive source
ρ density
ROT rotational
RSC radiation safety committee
RSO radiation safety officer
SK air-kerma strength
T occupancy factor
τ residence time of activity in patient
Te effective half-life of the nondecay corrected total-
body activity for a single exponential function
Te effective half-life of the nondecay corrected
i
total-body activity for component i of a multi-
exponential function

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204 / SYMBOLS AND ACRONYMS

tavoid period for avoiding women and children


tno hold period for not holding children
tno work period for not working after release from medi-
cal confinement
tsleep apart period for sleeping partners not sleeping
together
Tp physical half-life
Γbr specific bremsstrahlung constant (Table 3.1)
Γγ specific gamma-ray constant
Γδ exposure-rate constant
(trelease)limit time of patient release from medical confine-
ment based on particular effective-dose limit
Tr occupancy factor for an individual at a distance
j
from a radioactive patient
TVL tenth-value layer
TVLe equilibrium tenth-value layer
U unit of air-kerma strength
U use factor
W workload
wR radiation weighting factor
wT tissue weighting factor
X exposure

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The NCRP

The National Council on Radiation Protection and Measurements is a non-


profit corporation chartered by Congress in 1964 to:

1. Collect, analyze, develop and disseminate in the public interest infor-


mation and recommendations about (a) protection against radiation
and (b) radiation measurements, quantities and units, particularly
those concerned with radiation protection.
2. Provide a means by which organizations concerned with the scientific
and related aspects of radiation protection and of radiation quantities,
units and measurements may cooperate for effective utilization of their
combined resources, and to stimulate the work of such organizations.
3. Develop basic concepts about radiation quantities, units and mea-
surements, about the application of these concepts, and about radiation
protection.
4. Cooperate with the International Commission on Radiological Protec-
tion, the International Commission on Radiation Units and Measure-
ments, and other national and international organizations,
governmental and private, concerned with radiation quantities, units
and measurements and with radiation protection.

The Council is the successor to the unincorporated association of scientists


known as the National Committee on Radiation Protection and Measurements
and was formed to carry on the work begun by the Committee in 1929.
The participants in the Council’s work are the Council members and mem-
bers of scientific and administrative committees. Council members are selected
solely on the basis of their scientific expertise and serve as individuals, not as
representatives of any particular organization. The scientific committees, com-
posed of experts having detailed knowledge and competence in the particular
area of the committee's interest, draft proposed recommendations. These are
then submitted to the full membership of the Council for careful review and
approval before being published.
The following comprise the current officers and membership of the Council:

Officers

President Thomas S. Tenforde


Senior Vice President Kenneth R. Kase
Secretary and Treasurer David A. Schauer

225

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Members
John F. Ahearne Thomas F. Gesell David S. Myers
Edward S. Amis, Jr. Ronald E. Goans Bruce A. Napier
Sally A. Amundson Robert L. Goldberg Gregory A. Nelson
Kimberly E. Applegate Raymond A. Guilmette Carl J. Paperiello
Benjamin R. Archer Roger W. Harms R. Julian Preston
Stephen Balter Kathryn Held Jerome C. Puskin
Steven M. Becker John W. Hirshfeld, Jr. Abram Recht
Joel S. Bedford F. Owen Hoffman Allan C.B. Richardson
Eleanor A. Blakely Roger W. Howell Henry D. Royal
William F. Blakely Timothy J. Jorgensen Michael T. Ryan
John D. Boice, Jr. Kenneth R. Kase Jonathan M. Samet
Wesley E. Bolch Ann R. Kennedy Thomas M. Seed
Thomas B. Borak William E. Kennedy, Jr. Stephen M. Seltzer
Andre Bouville David C. Kocher Roy E. Shore
Leslie A. Braby Ritsuko Komaki Edward A. Sickles
David J. Brenner Amy Kronenberg Steven L. Simon
James A. Brink Susan M. Langhorst Paul Slovic
Antone L. Brooks Edwin M. Leidholdt Christopher G. Soares
Jerrold T. Bushberg Howard L. Liber Daniel J. Strom
John F. Cardella James C. Lin Thomas S. Tenforde
Stephanie K. Carlson Jill A. Lipoti Julie E.K. Timins
Charles E. Chambers John B. Little Richard E. Toohey
Polly Y. Chang Paul A. Locke Lawrence W. Townsend
S.Y. Chen Jay H. Lubin Fong Y. Tsai
Kelly L. Classic C. Douglas Maynard Richard J. Vetter
Mary E. Clark Debra McBaugh Chris G. Whipple
Michael L. Corradini Ruth E. McBurney Stuart C. White
Allen G. Croff Cynthia H. McCollough J. Frank Wilson
Paul M. DeLuca Barbara J. McNeil Susan D. Wiltshire
David A. Eastmond Fred A. Mettler, Jr. Gayle E. Woloschak
Stephen A. Feig Charles W. Miller Shiao Y. Woo
John R. Frazier Donald L. Miller Andrew J. Wyrobek
Donald P. Frush William H. Miller Marco A. Zaider
William F. Morgan

Distinguished Emeritus Members


Warren K. Sinclair, President Emeritus; Charles B. Meinhold, President Emeritus
S. James Adelstein, Honorary Vice President
W. Roger Ney, Executive Director Emeritus
William M. Beckner, Executive Director Emeritus
Seymour Abrahamson Keith F. Eckerman Dade W. Moeller
Lynn R. Anspaugh Thomas S. Ely A. Alan Moghissi
John A. Auxier Richard F. Foster Wesley L. Nyborg
William J. Bair R.J. Michael Fry John W. Poston, Sr.
Harold L. Beck Ethel S. Gilbert Andrew K. Poznanski
Bruce B. Boecker Joel E. Gray Genevieve S. Roessler
Robert L. Brent Robert O. Gorson Marvin Rosenstein
Reynold F. Brown Arthur W. Guy Lawrence N. Rothenberg
Randall S. Caswell Eric J. Hall Eugene L. Saenger
J. Donald Cossairt Naomi H. Harley William J. Schull
James F. Crow William R. Hendee John E. Till
Gerald D. Dodd Donald G. Jacobs Robert L. Ullrich
Sarah S. Donaldson Bernd Kahn Arthur C. Upton
William P. Dornsife Charles E. Land F. Ward Whicker
Patricia W. Durbin Roger O. McClellan Marvin C. Ziskin
Kenneth L. Miller

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Lauriston S. Taylor Lecturers


Patricia W. Durbin (2007) The Quest for Therapeutic Actinide Chelators
Robert L. Brent (2006) Fifty Years of Scientific Research: The Importance of
Scholarship and the Influence of Politics and Controversy
John B. Little (2005) Nontargeted Effects of Radiation: Implications for
Low-Dose Exposures
Abel J. Gonzalez (2004) Radiation Protection in the Aftermath of a Terrorist
Attack Involving Exposure to Ionizing Radiation
Charles B. Meinhold (2003) The Evolution of Radiation Protection: From
Erythema to Genetic Risks to Risks of Cancer to ?
R. Julian Preston (2002) Developing Mechanistic Data for Incorporation into
Cancer Risk Assessment: Old Problems and New Approaches
Wesley L. Nyborg (2001) Assuring the Safety of Medical Diagnostic Ultrasound
S. James Adelstein (2000) Administered Radioactivity: Unde Venimus Quoque
Imus
Naomi H. Harley (1999) Back to Background
Eric J. Hall (1998) From Chimney Sweeps to Astronauts: Cancer Risks in the
Workplace
William J. Bair (1997) Radionuclides in the Body: Meeting the Challenge!
Seymour Abrahamson (1996) 70 Years of Radiation Genetics: Fruit Flies, Mice
and Humans
Albrecht Kellerer (1995) Certainty and Uncertainty in Radiation Protection
R.J. Michael Fry (1994) Mice, Myths and Men
Warren K. Sinclair (1993) Science, Radiation Protection and the NCRP
Edward W. Webster (1992) Dose and Risk in Diagnostic Radiology: How Big?
How Little?
Victor P. Bond (1991) When is a Dose Not a Dose?
J. Newell Stannard (1990) Radiation Protection and the Internal Emitter Saga
Arthur C. Upton (1989) Radiobiology and Radiation Protection: The Past Cen-
tury and Prospects for the Future
Bo Lindell (1988) How Safe is Safe Enough?
Seymour Jablon (1987) How to be Quantitative about Radiation Risk Estimates
Herman P. Schwan (1986) Biological Effects of Non-ionizing Radiations: Cellu-
lar Properties and Interactions
John H. Harley (1985) Truth (and Beauty) in Radiation Measurement
Harald H. Rossi (1984) Limitation and Assessment in Radiation Protection
Merril Eisenbud (1983) The Human Environment—Past, Present and Future
Eugene L. Saenger (1982) Ethics, Trade-Offs and Medical Radiation
James F. Crow (1981) How Well Can We Assess Genetic Risk? Not Very
Harold O. Wyckoff (1980) From “Quantity of Radiation” and “Dose” to “Expo-
sure” and “Absorbed Dose”—An Historical Review
Hymer L. Friedell (1979) Radiation Protection—Concepts and Trade Offs
Sir Edward Pochin (1978) Why be Quantitative about Radiation Risk
Estimates?
Herbert M. Parker (1977) The Squares of the Natural Numbers in Radiation
Protection

Currently, the following committees are actively engaged in formulating


recommendations:

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Program Area Committee 1: Basic Criteria, Epidemiology,


Radiobiology, and Risk
SC 1-8 Risk to Thyroid from Ionizing Radiation
SC 1-13 Impact of Individual Susceptibility and Previous Radiation
Exposure on Radiation Risk for Astronauts
SC 1-15 Radiation Safety in NASA Lunar Missions’
SC 1-17 Second Cancers and Cardiopulmonary Effects After Radiotherapy
SC 85 Risk of Lung Cancer from Radon
Program Area Committee 2: Operational Radiation Safety
SC 2-3 Radiation Safety Issues for Image-Guided Interventional Medical
Procedures
SC 2-4 Self Assessment of Radiation Safety Programs
SC 46-17 Radiation Protection in Educational Institutions
Program Area Committee 3: Nonionizing Radiation
Program Area Committee 4: Radiation Protection in Medicine
SC 4-1 Management of Persons Contaminated with Radionuclides
SC 4-2 Population Monitoring and Decontamination Following a Nuclear/
Radiological Incident
Program Area Committee 5: Environmental Radiation and
Radioactive Waste Issues
SC 64-22 Design of Effective Effluent and Environmental Monitoring
Programs
Program Area Committee 6: Radiation Measurements and
Dosimetry
SC 6-1 Uncertainties in the Measurement and Dosimetry of External
Radiation Sources
SC 6-2 Radiation Exposure of the U.S. Population
SC 6-3 Uncertainties in Internal Radiation Dosimetry
SC 6-4 Fundamental Principles of Dose Reconstruction
SC 6-5 Radiation Protection and Measurement Issues Related to Cargo
Scanning with High-Energy X Rays Produced by Accelerators
SC 6-6 Skin Doses from Dermal Contamination
SC 6-7 Evaluation of Inhalation Doses in Scenarios Involving Resuspension
by Nuclear Detonations at the Nevada Test Site

In recognition of its responsibility to facilitate and stimulate cooperation


among organizations concerned with the scientific and related aspects of radi-
ation protection and measurement, the Council has created a category of NCRP
Collaborating Organizations. Organizations or groups of organizations that are
national or international in scope and are concerned with scientific problems
involving radiation quantities, units, measurements and effects, or radiation
protection may be admitted to collaborating status by the Council. Collaborat-
ing Organizations provide a means by which NCRP can gain input into its
activities from a wider segment of society. At the same time, the relationships
with the Collaborating Organizations facilitate wider dissemination of infor-
mation about the Council's activities, interests and concerns. Collaborating
Organizations have the opportunity to comment on draft reports (at the time
that these are submitted to the members of the Council). This is intended to
capitalize on the fact that Collaborating Organizations are in an excellent posi-
tion to both contribute to the identification of what needs to be treated in NCRP

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reports and to identify problems that might result from proposed recommenda-
tions. The present Collaborating Organizations with which NCRP maintains
liaison are as follows:

American Academy of Dermatology


American Academy of Environmental Engineers
American Academy of Health Physics
American Association of Physicists in Medicine
American College of Medical Physics
American College of Nuclear Physicians
American College of Occupational and Environmental Medicine
American College of Radiology
American Conference of Governmental Industrial Hygienists
American Dental Association
American Industrial Hygiene Association
American Institute of Ultrasound in Medicine
American Medical Association
American Nuclear Society
American Pharmaceutical Association
American Podiatric Medical Association
American Public Health Association
American Radium Society
American Roentgen Ray Society
American Society for Therapeutic Radiology and Oncology
American Society of Emergency Radiology
American Society of Health-System Pharmacists
American Society of Radiologic Technologists
Association of Educators in Imaging and Radiological Sciences
Association of University Radiologists
Bioelectromagnetics Society
Campus Radiation Safety Officers
College of American Pathologists
Conference of Radiation Control Program Directors, Inc.
Council on Radionuclides and Radiopharmaceuticals
Defense Threat Reduction Agency
Electric Power Research Institute
Federal Communications Commission
Federal Emergency Management Agency
Genetics Society of America
Health Physics Society
Institute of Electrical and Electronics Engineers, Inc.
Institute of Nuclear Power Operations
International Brotherhood of Electrical Workers
National Aeronautics and Space Administration
National Association of Environmental Professionals
National Center for Environmental Health/Agency for Toxic Substances
National Electrical Manufacturers Association
National Institute for Occupational Safety and Health
National Institute of Standards and Technology
Nuclear Energy Institute

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Office of Science and Technology Policy


Paper, Allied-Industrial, Chemical and Energy Workers International
Union
Product Stewardship Institute
Radiation Research Society
Radiological Society of North America
Society for Cardiovascular Angiography and Interventions
Society for Risk Analysis
Society of Chairmen of Academic Radiology Departments
Society of Interventional Radiology
Society of Nuclear Medicine
Society of Radiologists in Ultrasound
Society of Skeletal Radiology
U.S. Air Force
U.S. Army
U.S. Coast Guard
U.S. Department of Energy
U.S. Department of Housing and Urban Development
U.S. Department of Labor
U.S. Department of Transportation
U.S. Environmental Protection Agency
U.S. Navy
U.S. Nuclear Regulatory Commission
U.S. Public Health Service
Utility Workers Union of America

NCRP has found its relationships with these organizations to be extremely


valuable to continued progress in its program.
Another aspect of the cooperative efforts of NCRP relates to the Special
Liaison relationships established with various governmental organizations
that have an interest in radiation protection and measurements. This liaison
relationship provides: (1) an opportunity for participating organizations to des-
ignate an individual to provide liaison between the organization and NCRP;
(2) that the individual designated will receive copies of draft NCRP reports (at
the time that these are submitted to the members of the Council) with an invi-
tation to comment, but not vote; and (3) that new NCRP efforts might be dis-
cussed with liaison individuals as appropriate, so that they might have an
opportunity to make suggestions on new studies and related matters. The fol-
lowing organizations participate in the Special Liaison Program:

Australian Radiation Laboratory


Bundesamt fur Strahlenschutz (Germany)
Canadian Nuclear Safety Commission
Central Laboratory for Radiological Protection (Poland)
China Institute for Radiation Protection
Commissariat a l’Energie Atomique (France)
Commonwealth Scientific Instrumentation Research Organization
(Australia)
European Commission
Health Council of the Netherlands
Health Protection Agency

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International Commission on Non-ionizing Radiation Protection


International Commission on Radiation Units and Measurements
Japan Radiation Council
Korea Institute of Nuclear Safety
Russian Scientific Commission on Radiation Protection
South African Forum for Radiation Protection
World Association of Nuclear Operators
World Health Organization, Radiation and Environmental Health

NCRP values highly the participation of these organizations in the Special


Liaison Program.
The Council also benefits significantly from the relationships established
pursuant to the Corporate Sponsor's Program. The program facilitates the
interchange of information and ideas and corporate sponsors provide valuable
fiscal support for the Council's program. This developing program currently
includes the following Corporate Sponsors:

3M
Duke Energy Corporation
GE Healthcare
Global Dosimetry Solutions, Inc.
Landauer, Inc.
Nuclear Energy Institute

The Council's activities have been made possible by the voluntary contribu-
tion of time and effort by its members and participants and the generous
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3M Health Physics Services


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American Academy of Health Physics
American Academy of Oral and Maxillofacial Radiology
American Association of Physicists in Medicine
American Cancer Society
American College of Medical Physics
American College of Nuclear Physicians
American College of Occupational and Environmental Medicine
American College of Radiology
American College of Radiology Foundation
American Dental Association
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American Industrial Hygiene Association
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American Radium Society


American Roentgen Ray Society
American Society of Radiologic Technologists
American Society for Therapeutic Radiology and Oncology
American Veterinary Medical Association
American Veterinary Radiology Society
Association of Educators in Radiological Sciences, Inc.
Association of University Radiologists
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Global Dosimetry Solutions
Health Effects Research Foundation (Japan)
Health Physics Society
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Institute of Nuclear Power Operations
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Radiological Society of North America


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NCRP seeks to promulgate information and recommendations based on
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ters. These efforts are intended to serve the public interest and the Council
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NCRP Publications

NCRP publications can be obtained online in both hard- and soft-copy


(downloadable PDF) formats at http://NCRPpublications.org. Professional soci-
eties can arrange for discounts for their members by contacting NCRP. Addi-
tional information on NCRP publications may be obtained from the NCRP
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7910 Woodmont Avenue
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Abstracts of NCRP reports published since 1980, abstracts of all NCRP com-
mentaries, and the text of all NCRP statements are available at the NCRP
website. Currently available publications are listed below.

NCRP Reports
No. Title
8 Control and Removal of Radioactive Contamination in Laboratories
(1951)
22 Maximum Permissible Body Burdens and Maximum Permissible
Concentrations of Radionuclides in Air and in Water for Occupational
Exposure (1959) [includes Addendum 1 issued in August 1963]
25 Measurement of Absorbed Dose of Neutrons, and of Mixtures of
Neutrons and Gamma Rays (1961)
27 Stopping Powers for Use with Cavity Chambers (1961)
30 Safe Handling of Radioactive Materials (1964)
32 Radiation Protection in Educational Institutions (1966)
35 Dental X-Ray Protection (1970)
36 Radiation Protection in Veterinary Medicine (1970)
37 Precautions in the Management of Patients Who Have Received
Therapeutic Amounts of Radionuclides (1970)
38 Protection Against Neutron Radiation (1971)
40 Protection Against Radiation from Brachytherapy Sources (1972)
41 Specification of Gamma-Ray Brachytherapy Sources (1974)
42 Radiological Factors Affecting Decision-Making in a Nuclear Attack
(1974)
44 Krypton-85 in the Atmosphere—Accumulation, Biological
Significance, and Control Technology (1975)
46 Alpha-Emitting Particles in Lungs (1975)

234

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47 Tritium Measurement Techniques (1976)


49 Structural Shielding Design and Evaluation for Medical Use of
X Rays and Gamma Rays of Energies Up to 10 MeV (1976)
50 Environmental Radiation Measurements (1976)
52 Cesium-137 from the Environment to Man: Metabolism and Dose
(1977)
54 Medical Radiation Exposure of Pregnant and Potentially Pregnant
Women (1977)
55 Protection of the Thyroid Gland in the Event of Releases of
Radioiodine (1977)
57 Instrumentation and Monitoring Methods for Radiation Protection
(1978)
58 A Handbook of Radioactivity Measurements Procedures, 2nd ed.
(1985)
60 Physical, Chemical, and Biological Properties of Radiocerium
Relevant to Radiation Protection Guidelines (1978)
61 Radiation Safety Training Criteria for Industrial Radiography (1978)
62 Tritium in the Environment (1979)
63 Tritium and Other Radionuclide Labeled Organic Compounds
Incorporated in Genetic Material (1979)
64 Influence of Dose and Its Distribution in Time on Dose-Response
Relationships for Low-LET Radiations (1980)
65 Management of Persons Accidentally Contaminated with
Radionuclides (1980)
67 Radiofrequency Electromagnetic Fields—Properties, Quantities and
Units, Biophysical Interaction, and Measurements (1981)
68 Radiation Protection in Pediatric Radiology (1981)
69 Dosimetry of X-Ray and Gamma-Ray Beams for Radiation Therapy in
the Energy Range 10 keV to 50 MeV (1981)
70 Nuclear Medicine—Factors Influencing the Choice and Use of
Radionuclides in Diagnosis and Therapy (1982)
72 Radiation Protection and Measurement for Low-Voltage Neutron
Generators (1983)
73 Protection in Nuclear Medicine and Ultrasound Diagnostic
Procedures in Children (1983)
74 Biological Effects of Ultrasound: Mechanisms and Clinical
Implications (1983)
75 Iodine-129: Evaluation of Releases from Nuclear Power Generation
(1983)
76 Radiological Assessment: Predicting the Transport, Bioaccumulation,
and Uptake by Man of Radionuclides Released to the Environment
(1984)
77 Exposures from the Uranium Series with Emphasis on Radon and Its
Daughters (1984)
78 Evaluation of Occupational and Environmental Exposures to Radon
and Radon Daughters in the United States (1984)
79 Neutron Contamination from Medical Electron Accelerators (1984)
80 Induction of Thyroid Cancer by Ionizing Radiation (1985)
81 Carbon-14 in the Environment (1985)
82 SI Units in Radiation Protection and Measurements (1985)

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83 The Experimental Basis for Absorbed-Dose Calculations in Medical


Uses of Radionuclides (1985)
84 General Concepts for the Dosimetry of Internally Deposited
Radionuclides (1985)
86 Biological Effects and Exposure Criteria for Radiofrequency
Electromagnetic Fields (1986)
87 Use of Bioassay Procedures for Assessment of Internal Radionuclide
Deposition (1987)
88 Radiation Alarms and Access Control Systems (1986)
89 Genetic Effects from Internally Deposited Radionuclides (1987)
90 Neptunium: Radiation Protection Guidelines (1988)
92 Public Radiation Exposure from Nuclear Power Generation in the
United States (1987)
93 Ionizing Radiation Exposure of the Population of the United States
(1987)
94 Exposure of the Population in the United States and Canada from
Natural Background Radiation (1987)
95 Radiation Exposure of the U.S. Population from Consumer Products
and Miscellaneous Sources (1987)
96 Comparative Carcinogenicity of Ionizing Radiation and Chemicals
(1989)
97 Measurement of Radon and Radon Daughters in Air (1988)
99 Quality Assurance for Diagnostic Imaging (1988)
100 Exposure of the U.S. Population from Diagnostic Medical Radiation
(1989)
101 Exposure of the U.S. Population from Occupational Radiation (1989)
102 Medical X-Ray, Electron Beam and Gamma-Ray Protection for
Energies Up to 50 MeV (Equipment Design, Performance and Use)
(1989)
103 Control of Radon in Houses (1989)
104 The Relative Biological Effectiveness of Radiations of Different
Quality (1990)
105 Radiation Protection for Medical and Allied Health Personnel (1989)
106 Limit for Exposure to “Hot Particles” on the Skin (1989)
107 Implementation of the Principle of As Low As Reasonably Achievable
(ALARA) for Medical and Dental Personnel (1990)
108 Conceptual Basis for Calculations of Absorbed-Dose Distributions
(1991)
109 Effects of Ionizing Radiation on Aquatic Organisms (1991)
110 Some Aspects of Strontium Radiobiology (1991)
111 Developing Radiation Emergency Plans for Academic, Medical or
Industrial Facilities (1991)
112 Calibration of Survey Instruments Used in Radiation Protection for
the Assessment of Ionizing Radiation Fields and Radioactive Surface
Contamination (1991)
113 Exposure Criteria for Medical Diagnostic Ultrasound: I. Criteria
Based on Thermal Mechanisms (1992)
114 Maintaining Radiation Protection Records (1992)
115 Risk Estimates for Radiation Protection (1993)
116 Limitation of Exposure to Ionizing Radiation (1993)

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117 Research Needs for Radiation Protection (1993)


118 Radiation Protection in the Mineral Extraction Industry (1993)
119 A Practical Guide to the Determination of Human Exposure to
Radiofrequency Fields (1993)
120 Dose Control at Nuclear Power Plants (1994)
121 Principles and Application of Collective Dose in Radiation Protection
(1995)
122 Use of Personal Monitors to Estimate Effective Dose Equivalent and
Effective Dose to Workers for External Exposure to Low-LET
Radiation (1995)
123 Screening Models for Releases of Radionuclides to Atmosphere,
Surface Water, and Ground (1996)
124 Sources and Magnitude of Occupational and Public Exposures from
Nuclear Medicine Procedures (1996)
125 Deposition, Retention and Dosimetry of Inhaled Radioactive
Substances (1997)
126 Uncertainties in Fatal Cancer Risk Estimates Used in Radiation
Protection (1997)
127 Operational Radiation Safety Program (1998)
128 Radionuclide Exposure of the Embryo/Fetus (1998)
129 Recommended Screening Limits for Contaminated Surface Soil and
Review of Factors Relevant to Site-Specific Studies (1999)
130 Biological Effects and Exposure Limits for “Hot Particles” (1999)
131 Scientific Basis for Evaluating the Risks to Populations from Space
Applications of Plutonium (2001)
132 Radiation Protection Guidance for Activities in Low-Earth Orbit
(2000)
133 Radiation Protection for Procedures Performed Outside the Radiology
Department (2000)
134 Operational Radiation Safety Training (2000)
135 Liver Cancer Risk from Internally-Deposited Radionuclides (2001)
136 Evaluation of the Linear-Nonthreshold Dose-Response Model for
Ionizing Radiation (2001)
137 Fluence-Based and Microdosimetric Event-Based Methods for
Radiation Protection in Space (2001)
138 Management of Terrorist Events Involving Radioactive Material
(2001)
139 Risk-Based Classification of Radioactive and Hazardous Chemical
Wastes (2002)
140 Exposure Criteria for Medical Diagnostic Ultrasound: II. Criteria
Based on all Known Mechanisms (2002)
141 Managing Potentially Radioactive Scrap Metal (2002)
142 Operational Radiation Safety Program for Astronauts in Low-Earth
Orbit: A Basic Framework (2002)
143 Management Techniques for Laboratories and Other Small
Institutional Generators to Minimize Off-Site Disposal of Low-Level
Radioactive Waste (2003)
144 Radiation Protection for Particle Accelerator Facilities (2003)
145 Radiation Protection in Dentistry (2003)

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146 Approaches to Risk Management in Remediation of Radioactively


Contaminated Sites (2004)
147 Structural Shielding Design for Medical X-Ray Imaging Facilities
(2004)
148 Radiation Protection in Veterinary Medicine (2004)
149 A Guide to Mammography and Other Breast Imaging Procedures
(2004)
150 Extrapolation of Radiation-Induced Cancer Risks from Nonhuman
Experimental Systems to Humans (2005)
151 Structural Shielding Design and Evaluation for Megavoltage X- and
Gamma-Ray Radiotherapy Facilities (2005)
152 Performance Assessment of Near-Surface Facilities for Disposal of
Low-Level Radioactive Waste (2005)
153 Information Needed to Make Radiation Protection Recommendations
for Space Missions Beyond Low-Earth Orbit (2006)
154 Cesium-137 in the Environment: Radioecology and Approaches to
Assessment and Management (2006)
155 Management of Radionuclide Therapy Patients (2006)

Binders for NCRP reports are available. Two sizes make it possible to col-
lect into small binders the “old series” of reports (NCRP Reports Nos. 8–30) and
into large binders the more recent publications (NCRP Reports Nos. 32–155).
Each binder will accommodate from five to seven reports. The binders carry the
identification “NCRP Reports” and come with label holders which permit the
user to attach labels showing the reports contained in each binder.
The following bound sets of NCRP reports are also available:

Volume I. NCRP Reports Nos. 8, 22


Volume II. NCRP Reports Nos. 23, 25, 27, 30
Volume III. NCRP Reports Nos. 32, 35, 36, 37
Volume IV. NCRP Reports Nos. 38, 40, 41
Volume V. NCRP Reports Nos. 42, 44, 46
Volume VI. NCRP Reports Nos. 47, 49, 50, 51
Volume VII. NCRP Reports Nos. 52, 53, 54, 55, 57
Volume VIII. NCRP Report No. 58
Volume IX. NCRP Reports Nos. 59, 60, 61, 62, 63
Volume X. NCRP Reports Nos. 64, 65, 66, 67
Volume XI. NCRP Reports Nos. 68, 69, 70, 71, 72
Volume XII. NCRP Reports Nos. 73, 74, 75, 76
Volume XIII. NCRP Reports Nos. 77, 78, 79, 80
Volume XIV. NCRP Reports Nos. 81, 82, 83, 84, 85
Volume XV. NCRP Reports Nos. 86, 87, 88, 89
Volume XVI. NCRP Reports Nos. 90, 91, 92, 93
Volume XVII. NCRP Reports Nos. 94, 95, 96, 97
Volume XVIII. NCRP Reports Nos. 98, 99, 100
Volume XIX. NCRP Reports Nos. 101, 102, 103, 104
Volume XX. NCRP Reports Nos. 105, 106, 107, 108
Volume XXI. NCRP Reports Nos. 109, 110, 111
Volume XXII. NCRP Reports Nos. 112, 113, 114
Volume XXIII. NCRP Reports Nos. 115, 116, 117, 118

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NCRP PUBLICATIONS / 239

Volume XXIV. NCRP Reports Nos. 119, 120, 121, 122


Volume XXV. NCRP Report No. 123I and 123II
Volume XXVI. NCRP Reports Nos. 124, 125, 126, 127
Volume XXVII. NCRP Reports Nos. 128, 129, 130
Volume XXVIII. NCRP Reports Nos. 131, 132, 133
Volume XXIX. NCRP Reports Nos. 134, 135, 136, 137
Volume XXX. NCRP Reports Nos. 138, 139
Volume XXXI. NCRP Report No. 140
Volume XXXII. NCRP Reports Nos. 141, 142, 143
Volume XXXIII. NCRP Report No. 144
Volume XXXIV. NCRP Reports Nos. 145, 146, 147
Volume XXXV. NCRP Reports Nos. 148, 149
Volume XXXVI. NCRP Reports Nos. 150, 151, 152

(Titles of the individual reports contained in each volume are given


previously.)

NCRP Commentaries
No. Title
1 Krypton-85 in the Atmosphere—With Specific Reference to the Public
Health Significance of the Proposed Controlled Release at Three Mile
Island (1980)
4 Guidelines for the Release of Waste Water from Nuclear Facilities with
Special Reference to the Public Health Significance of the Proposed
Release of Treated Waste Waters at Three Mile Island (1987)
5 Review of the Publication, Living Without Landfills (1989)
6 Radon Exposure of the U.S. Population—Status of the Problem (1991)
7 Misadministration of Radioactive Material in Medicine—Scientific
Background (1991)
8 Uncertainty in NCRP Screening Models Relating to Atmospheric
Transport, Deposition and Uptake by Humans (1993)
9 Considerations Regarding the Unintended Radiation Exposure of the
Embryo, Fetus or Nursing Child (1994)
10 Advising the Public about Radiation Emergencies: A Document for
Public Comment (1994)
11 Dose Limits for Individuals Who Receive Exposure from Radionuclide
Therapy Patients (1995)
12 Radiation Exposure and High-Altitude Flight (1995)
13 An Introduction to Efficacy in Diagnostic Radiology and Nuclear
Medicine (Justification of Medical Radiation Exposure) (1995)
14 A Guide for Uncertainty Analysis in Dose and Risk Assessments
Related to Environmental Contamination (1996)
15 Evaluating the Reliability of Biokinetic and Dosimetric Models and
Parameters Used to Assess Individual Doses for Risk Assessment
Purposes (1998)
16 Screening of Humans for Security Purposes Using Ionizing Radiation
Scanning Systems (2003)
17 Pulsed Fast Neutron Analysis System Used in Security Surveillance
(2003)

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18 Biological Effects of Modulated Radiofrequency Fields (2003)


19 Key Elements of Preparing Emergency Responders for Nuclear and
Radiological Terrorism (2005)

Proceedings of the Annual Meeting


No. Title
1 Perceptions of Risk, Proceedings of the Fifteenth Annual Meeting held
on March 14-15, 1979 (including Taylor Lecture No. 3) (1980)
3 Critical Issues in Setting Radiation Dose Limits, Proceedings of the
Seventeenth Annual Meeting held on April 8-9, 1981 (including
Taylor Lecture No. 5) (1982)
4 Radiation Protection and New Medical Diagnostic Approaches,
Proceedings of the Eighteenth Annual Meeting held on April 6-7,
1982 (including Taylor Lecture No. 6) (1983)
5 Environmental Radioactivity, Proceedings of the Nineteenth Annual
Meeting held on April 6-7, 1983 (including Taylor Lecture No. 7)
(1983)
6 Some Issues Important in Developing Basic Radiation Protection
Recommendations, Proceedings of the Twentieth Annual Meeting
held on April 4-5, 1984 (including Taylor Lecture No. 8) (1985)
7 Radioactive Waste, Proceedings of the Twenty-first Annual Meeting
held on April 3-4, 1985 (including Taylor Lecture No. 9)(1986)
8 Nonionizing Electromagnetic Radiations and Ultrasound,
Proceedings of the Twenty-second Annual Meeting held on April 2-3,
1986 (including Taylor Lecture No. 10) (1988)
9 New Dosimetry at Hiroshima and Nagasaki and Its Implications for
Risk Estimates, Proceedings of the Twenty-third Annual Meeting
held on April 8-9, 1987 (including Taylor Lecture No. 11) (1988)
10 Radon, Proceedings of the Twenty-fourth Annual Meeting held on
March 30-31, 1988 (including Taylor Lecture No. 12) (1989)
11 Radiation Protection Today—The NCRP at Sixty Years, Proceedings
of the Twenty-fifth Annual Meeting held on April 5-6, 1989 (including
Taylor Lecture No. 13) (1990)
12 Health and Ecological Implications of Radioactively Contaminated
Environments, Proceedings of the Twenty-sixth Annual Meeting held
on April 4-5, 1990 (including Taylor Lecture No. 14) (1991)
13 Genes, Cancer and Radiation Protection, Proceedings of the
Twenty-seventh Annual Meeting held on April 3-4, 1991 (including
Taylor Lecture No. 15) (1992)
14 Radiation Protection in Medicine, Proceedings of the Twenty-eighth
Annual Meeting held on April 1-2, 1992 (including Taylor Lecture
No. 16) (1993)
15 Radiation Science and Societal Decision Making, Proceedings of the
Twenty-ninth Annual Meeting held on April 7-8, 1993 (including
Taylor Lecture No. 17) (1994)
16 Extremely-Low-Frequency Electromagnetic Fields: Issues in
Biological Effects and Public Health, Proceedings of the Thirtieth
Annual Meeting held on April 6-7, 1994 (not published).

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17 Environmental Dose Reconstruction and Risk Implications,


Proceedings of the Thirty-first Annual Meeting held on April 12-13,
1995 (including Taylor Lecture No. 19) (1996)
18 Implications of New Data on Radiation Cancer Risk, Proceedings of
the Thirty-second Annual Meeting held on April 3-4, 1996 (including
Taylor Lecture No. 20) (1997)
19 The Effects of Pre- and Postconception Exposure to Radiation,
Proceedings of the Thirty-third Annual Meeting held on April 2-3,
1997, Teratology 59, 181–317 (1999)
20 Cosmic Radiation Exposure of Airline Crews, Passengers and
Astronauts, Proceedings of the Thirty-fourth Annual Meeting held on
April 1-2, 1998, Health Phys. 79, 466–613 (2000)
21 Radiation Protection in Medicine: Contemporary Issues, Proceedings
of the Thirty-fifth Annual Meeting held on April 7-8, 1999 (including
Taylor Lecture No. 23) (1999)
22 Ionizing Radiation Science and Protection in the 21st Century,
Proceedings of the Thirty-sixth Annual Meeting held on April 5-6,
2000, Health Phys. 80, 317–402 (2001)
23 Fallout from Atmospheric Nuclear Tests—Impact on Science and
Society, Proceedings of the Thirty-seventh Annual Meeting held on
April 4-5, 2001, Health Phys. 82, 573–748 (2002)
24 Where the New Biology Meets Epidemiology: Impact on Radiation
Risk Estimates, Proceedings of the Thirty-eighth Annual Meeting
held on April 10-11, 2002, Health Phys. 85, 1–108 (2003)
25 Radiation Protection at the Beginning of the 21st Century–A Look
Forward, Proceedings of the Thirty-ninth Annual Meeting held on
April 9–10, 2003, Health Phys. 87, 237–319 (2004)
26 Advances in Consequence Management for Radiological Terrorism
Events, Proceedings of the Fortieth Annual Meeting held on
April 14–15, 2004, Health Phys. 89, 415–588 (2005)
27 Managing the Disposition of Low-Activity Radioactive Materials,
Proceedings of the Forty-first Annual Meeting held on March 30–31,
2005, Health Phys. 91, 413–536 (2006)

Lauriston S. Taylor Lectures

No. Title
1 The Squares of the Natural Numbers in Radiation Protection by
Herbert M. Parker (1977)
2 Why be Quantitative about Radiation Risk Estimates? by Sir Edward
Pochin (1978)
3 Radiation Protection—Concepts and Trade Offs by Hymer L. Friedell
(1979) [available also in Perceptions of Risk, see above]
4 From “Quantity of Radiation” and “Dose” to “Exposure” and “Absorbed
Dose”—An Historical Review by Harold O. Wyckoff (1980)
5 How Well Can We Assess Genetic Risk? Not Very by James F. Crow
(1981) [available also in Critical Issues in Setting Radiation Dose
Limits, see above]

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6 Ethics, Trade-offs and Medical Radiation by Eugene L. Saenger


(1982) [available also in Radiation Protection and New Medical
Diagnostic Approaches, see above]
7 The Human Environment—Past, Present and Future by Merril
Eisenbud (1983) [available also in Environmental Radioactivity, see
above]
8 Limitation and Assessment in Radiation Protection by Harald H.
Rossi (1984) [available also in Some Issues Important in Developing
Basic Radiation Protection Recommendations, see above]
9 Truth (and Beauty) in Radiation Measurement by John H. Harley
(1985) [available also in Radioactive Waste, see above]
10 Biological Effects of Non-ionizing Radiations: Cellular Properties and
Interactions by Herman P. Schwan (1987) [available also in
Nonionizing Electromagnetic Radiations and Ultrasound, see above]
11 How to be Quantitative about Radiation Risk Estimates by Seymour
Jablon (1988) [available also in New Dosimetry at Hiroshima and
Nagasaki and its Implications for Risk Estimates, see above]
12 How Safe is Safe Enough? by Bo Lindell (1988) [available also in
Radon, see above]
13 Radiobiology and Radiation Protection: The Past Century and
Prospects for the Future by Arthur C. Upton (1989) [available also in
Radiation Protection Today, see above]
14 Radiation Protection and the Internal Emitter Saga by J. Newell
Stannard (1990) [available also in Health and Ecological Implications
of Radioactively Contaminated Environments, see above]
15 When is a Dose Not a Dose? by Victor P. Bond (1992) [available also in
Genes, Cancer and Radiation Protection, see above]
16 Dose and Risk in Diagnostic Radiology: How Big? How Little? by
Edward W. Webster (1992) [available also in Radiation Protection in
Medicine, see above]
17 Science, Radiation Protection and the NCRP by Warren K. Sinclair
(1993) [available also in Radiation Science and Societal Decision
Making, see above]
18 Mice, Myths and Men by R.J. Michael Fry (1995)
19 Certainty and Uncertainty in Radiation Research by Albrecht M.
Kellerer. Health Phys. 69, 446–453 (1995)
20 70 Years of Radiation Genetics: Fruit Flies, Mice and Humans by
Seymour Abrahamson. Health Phys. 71, 624–633 (1996)
21 Radionuclides in the Body: Meeting the Challenge by William J. Bair.
Health Phys. 73, 423–432 (1997)
22 From Chimney Sweeps to Astronauts: Cancer Risks in the Work Place
by Eric J. Hall. Health Phys. 75, 357–366 (1998)
23 Back to Background: Natural Radiation and Radioactivity Exposed
by Naomi H. Harley. Health Phys. 79, 121–128 (2000)
24 Administered Radioactivity: Unde Venimus Quoque Imus by S. James
Adelstein. Health Phys. 80, 317–324 (2001)
25 Assuring the Safety of Medical Diagnostic Ultrasound by Wesley L.
Nyborg. Health Phys. 82, 578–587 (2002)

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NCRP PUBLICATIONS / 243

26 Developing Mechanistic Data for Incorporation into Cancer and


Genetic Risk Assessments: Old Problems and New Approaches by R.
Julian Preston. Health Phys. 85, 4–12 (2003)
27 The Evolution of Radiation Protection–From Erythema to Genetic
Risks to Risks of Cancer to ? by Charles B. Meinhold, Health Phys. 87,
240–248 (2004)
28 Radiation Protection in the Aftermath of a Terrorist Attack Involving
Exposure to Ionizing Radiation by Abel J. Gonzalez, Health Phys. 89,
418–446 (2005)
29 Nontargeted Effects of Radiation: Implications for Low Dose
Exposures by John B. Little, Health Phys. 91, 416–426 (2006)

Symposium Proceedings
No. Title
1 The Control of Exposure of the Public to Ionizing Radiation in the
Event of Accident or Attack, Proceedings of a Symposium held
April 27-29, 1981 (1982)
2 Radioactive and Mixed Waste—Risk as a Basis for Waste
Classification, Proceedings of a Symposium held November 9, 1994
(1995)
3 Acceptability of Risk from Radiation—Application to Human Space
Flight, Proceedings of a Symposium held May 29, 1996 (1997)
4 21st Century Biodosimetry: Quantifying the Past and Predicting the
Future, Proceedings of a Symposium held February 22, 2001, Radiat.
Prot. Dosim. 97(1), (2001)
5 National Conference on Dose Reduction in CT, with an Emphasis on
Pediatric Patients, Summary of a Symposium held November 6-7,
2002, Am. J. Roentgenol. 181(2), 321–339 (2003)

NCRP Statements

No. Title
1 “Blood Counts, Statement of the National Committee on Radiation
Protection,” Radiology 63, 428 (1954)
2 “Statements on Maximum Permissible Dose from Television
Receivers and Maximum Permissible Dose to the Skin of the Whole
Body,” Am. J. Roentgenol., Radium Ther. and Nucl. Med. 84, 152
(1960) and Radiology 75, 122 (1960)
3 X-Ray Protection Standards for Home Television Receivers, Interim
Statement of the National Council on Radiation Protection and
Measurements (1968)
4 Specification of Units of Natural Uranium and Natural Thorium,
Statement of the National Council on Radiation Protection and
Measurements (1973)
5 NCRP Statement on Dose Limit for Neutrons (1980)
6 Control of Air Emissions of Radionuclides (1984)
7 The Probability That a Particular Malignancy May Have Been Caused
by a Specified Irradiation (1992)
8 The Application of ALARA for Occupational Exposures (1999)

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9 Extension of the Skin Dose Limit for Hot Particles to Other External
Sources of Skin Irradiation (2001)
10 Recent Applications of the NCRP Public Dose Limit Recommendation
for Ionizing Radiation (2004)

Other Documents
The following documents were published outside of the NCRP report, com-
mentary and statement series:

Somatic Radiation Dose for the General Population, Report of the Ad Hoc
Committee of the National Council on Radiation Protection and
Measurements, 6 May 1959, Science 131 (3399), February 19,
482–486 (1960)
Dose Effect Modifying Factors in Radiation Protection, Report of
Subcommittee M-4 (Relative Biological Effectiveness) of the National
Council on Radiation Protection and Measurements, Report BNL
50073 (T-471) (1967) Brookhaven National Laboratory (National
Technical Information Service, Springfield, Virginia)
Residential Radon Exposure and Lung Cancer Risk: Commentary on
Cohen's County-Based Study, Health Phys. 87(6), 656–658 (2004)

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Index

Absorbed dose (D) 142 low dose-rate remote 89, 90, 96,
Absorbed-dose determination, 97
brachytherapy 78–80 manual 92–94
isotropic point-source model 78, “pulsed” dose-rate remote 91, 92
79 Airborne activity 32, 33
Monte-Carlo photon-transport control of production 32, 33
model 80 measurement 33
Addressable events, Air kerma (Ka) 77, 142
brachytherapy 102–104 Air-kerma strength (SK) 77
evaluation and remediation 103, Ambient exposure rates 30, 31
104 calibration 30, 31
examples 103 conversion to dose units 31
occurrence 102 instruments 30, 31
Addressable events, measurement 30, 31
radiopharmaceutical therapy 55, As low as reasonably achievable
56 (ALARA) 15–17, 27
definition 55
evaluation and care of patient Bioassay 20, 21, 33–35
55, 56 definition 33, 34
examples 55 example 20, 21
reporting 55 measurement 34
review of event and remediation minimization of occurrence 34,
56 35
Administered activity, Brachytherapy 71–110
radiotherapeutic 50–55 addressable events 102–104
acceptance criteria 52, 53 experimental sources 85, 86
accuracy 52, 53 high dose-rate emergency
administration 53, 54 procedures and requirements
assay 50–52 101–102
identity of patient 54, 55 implant techniques 71, 72
responsible person 50, 52 HDR therapy 84, 85
verification 54 LDR intracavity therapy 81–83
Afterloading systems 88–94, LDR permanent interstitial
97–102 therapy 83, 84
high dose-rate emergency newer applications 106–110
procedures and requirements off hours emergency response
101, 102 106
high dose-rate remote 90, 91, radionuclide properties 75, 76,
97–100 81

245

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readmission 104–106 patient care during treatment


source calibration laboratories, 94, 95
NIST and ADCL 78 Breast feeding (see special
source dose rates (LDR and considerations for female
HDR) 73, 74 patients)
source type 73, 74–76 Burial of patient 137, 138
specification of photon source with embalming 138
output as air kerma (K), air without autopsy 137, 138
kerma strength (SK) and without embalming 137, 138
integrated reference air kerma
(IRAK) 76–78, 82 Cardiac arrest of patient 130, 131
specific precautions and Changes in medical status of the
procedures 92–102 radioactive patient 130–140
temporary implant technology cardiac or respiratory arrest 130,
72, 74, 76 131
tissue absorbed-dose death of patient 134–140
determination 78–80 emergency surgery 131, 132
treatment delivery technology examples of changes 130
86–92 patient mental status 131
Brachytherapy delivery patient on dialysis 132, 133
technology (see treatment patient transfer to a health care
delivery technology for facility 133, 134
brachytherapy) qualified experts 130
Brachytherapy facility design (see radiation safety 130
facility design, brachytherapy) readmission of patient 134
Brachytherapy, newer Clean up of patient confinement
applications 106–110 room 64, 65
balloon application for Clinical requirements for
irradiation of tumor-excised radiopharmaceutical therapy
surgical cavity surface 109, 45–60, 61–70
110 addressable events 55, 56
high dose rate for intraoperative administration of activity 53–55
therapy 109 assay of administered activity
intravascular therapy 106–108 50–52
new radionuclides 108, 109 commonly used radionuclides
Brachytherapy, principles 10–13 and compounds 46
general considerations 12, 13 female patient considerations
Brachytherapy specific 57–59
precautions and procedures imaging applications 67–70
92–102 instrumentation for in vivo,
high dose-rate remote in vitro, and imaging 47, 48
afterloading 97–102 patient confinement 56, 57
low dose-rate remote patient-release criteria 65–67
afterloading 96, 97 prescription of administered
manual afterloading 92–94 activity 49, 50
patient care during source radionuclide acceptance criteria
removal 95, 96 52, 53

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INDEX / 247

responsible person for radiation precaution


administration 50, 52 indentifications on body and
specific radiation safety shroud 136
procedures 61–65 Design of facilities 111–129
Conditions for travel by released brachytherapy 115–126
patients 66, 67 general considerations
Confinement of patients 62, 63, 64 applicable to both therapies
Contamination 31, 32 111–115
measurement 31, 32 radiopharmaceutical therapy
removal 32 126–129
Cremation 138–140 Dialysis, patient on 132, 133
contamination of the retort 139, potential for increased radiation
140 exposure due to longer
clearance rate 132
exposure of the crematorium
personnel 139 use of trial radioactive material
for testing clearance rate 132,
exposure of the public 139
133
handling the ash 138, 139
waste disposal of equipment and
informing the crematorium
liquids 133
personnel 138, 139
Dose equivalent (H) 142
transportation of body 138
Dose limits (see recommended dose
types of hazards 139 limits)
Dose prescription, current 67
Death of the patient 134–140 Dosimetry for patient-release
avoidance of therapeutic criteria 141–144
radionuclides to moribund
patient 134 Effective dose (E) 143, 144
burial without autopsy and effective dose limit (Elimit) 144
embalming 137, 138 Emergency, off hours response 106
cremation 138–140 Emergency surgery for patient
death outside of treating facility, 131, 132
minimal safety precautions immediate performance of
except for autopsy and surgery 131
cremation 135 precautions for patients with
death within treating facility, radiopharmaceuticals 132
decay of radionuclides and qualified experts 131
removal of temporary implants radiation exposure of surgical
134–135 staff 131, 132
embalming for burial 138 radiation safety evaluation of
organ donation, precautions patient, surgical staff, room
during harvesting and and equipment 131, 132
recipient radiation exposure Equivalent dose (HT) 143
not limited 135 Examples of patient-release
precautions during autopsy 136, operational-equation results
137 161–180
precautions during visitation hyperthyroidism, Example 2
138 169–174

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legal notice 161 photons versus beta rays 126,


metastatic carcinoid cancer, 127
Example 3 174–180 radionuclide dispensing
metastatic thyroid cancer, laboratory 127, 128
Example 1 162–168 Family member, definition 18
Experimental sources for Female patients (see special
brachytherapy 85, 86 considerations for female
Exposure of persons at home of patients)
radioactive patient 146–147
Exposure rates (see ambient Healthcare facilities, patient
exposure rates) transfer to (see transfer of
External-beam radiotherapy patient to another healthcare
(ERT) 4, 9, 10, 81 facility)
External radiation monitoring 33 Heritable effects and genetic
accredited vendors 33 counseling 59, 60
condition for use 33 avoidance of pregnancy after
therapy 60
risk 59
Facility design, brachytherapy
supporting literature 59, 60
111–126
High dose-rate brachytherapy
controlled and uncontrolled
sources 85, 86
areas and traffic 117
High dose-rate emergency
controlling factors for design 116
procedures and requirements
criteria for treatment area
101, 102
116–119
immediate actions 101, 102
general considerations 111–115
need for and conditions for
grouping of treatment rooms 117 indication 101
high dose-rate requirements responsibilities of medical
121–126 physicist and radiation
low dose-rate imaging 121 oncologist 102
low dose-rate requirements 119, High dose-rate facility design
121 111–115, 121–126
occupancy factors 118 essential safety features,
“pulsed” dose-rate requirements shielding, security, engineered
126 and administrative controls
required area resources 115 123–125
shielding, structural and four area types of treatment
portable 117–119, 120, 121, options 122, 123
123, 125–126, 186–195 general considerations 111–115
source preparation and storage shielding 117–119, 120, 121, 123,
120, 121 125–126, 186
Facility design, specific required areas 121
radiopharmaceutical 111–115, High dose-rate remote afterloading
126–129 97–102
general considerations 111–115 applicable conditions 97
low-level radioactive waste documentation, requirements
storage 128, 129 and records 98, 99

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quality assurance 99, 100 requirements and practices 128


treatment delivery 98 return sealed sources to vendor
Hyperthyroidism, Example 2 for 129
patient release based on types of waste 128
operational equations of
Appendix A 161, 169–174 Management of radiation safety
instructions to patient 172, 173 program 26, 27
legal notice 161 Management of radioactive
patient acknowledgement 174 sources 29, 30
patient data and evaluation 169 inventory 29
spreadsheet results 170, 171 receipt 29
storage 29, 30
Index distances 146, 147 Manual afterloading 88
Instrumentation 47–48 applications using catheters 88
for in vivo measurements 47–48 gynecological applications 88
surrogates for Medical facility, definition 18
nonphoton-emitting Medical physicist 23, 24
radionuclides 47 duties 23, 24
Intravascular brachytherapy qualification 23
106–108 Medical record, definition 18, 19
anatomical location 108 Members of the public, definition
failure of source retraction 108 18
stent- and catheter-based for Mental status of the patient 131
restenosis 106, 107 Metastatic carcinoid cancer,
treatment-room shielding 107, Example 3 for patient release
108 based on operational equations
Irradiation geometries 143, 144 of Appendix A 161, 175–180
Isolation of patients 62 instructions to patient 178, 179
Isotropic radiation geometry 143, legal notice 161
144 patient acknowledgement 180
patient data and evaluation 175
Location of patient death 134, 135 spreadsheet results 176, 177
in treatment facility 134 Metastatic thyroid cancer
outside treatment facility 135 Example 1 for patient release
Low dose-rate facility design based on operational equations
111–115, 119 of Appendix A 161, 162–168
general considerations 111–115 instructions to patient 166, 167
specific to low dose rate 119 legal notice 161
specific to pulsed dose rate 126 patient acknowledgement 168
Low dose-rate interstitial patient data and evaluation 161,
brachytherapy sources 83, 84 162
Low dose-rate intracavity spreadsheet results 164, 165
brachytherapy sources 81–83 Microspheres, use of 69, 70
Low-level radioactive waste
storage 128, 129 Nuclear-medicine physician 21, 22
long-term storage 129 duties 21, 22
patient waste 128 qualification 21

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Nuclear-medicine technologist 24, Patient confinement 56, 57


25 decision of nuclear-medicine
duties 24, 25 physician 56, 57
qualification 24, 25 need for 56
Nuclear pharmacist 23, 24 Patient death (see death of patient)
duties 23, 24 Patient-release criteria 65–67,
qualification 23 141–160
Nuclear-pharmacy laboratory (see conditions for travel by released
radiopharmaceutical dispensing patients 66, 67
laboratory) dose limits 144–146
dosimetry 141–144
Occupancy factors 118, 146, 147, exposed groups 144, 145, 147
188 index distances 146, 147
Operational equations for time of NRC approval of dose-based
patient release from radiation release criteria 145, 146
confinement for various occupancy factors 146, 147
conditions 147–160 operational equations for time of
examples of patient-release release 147–160
operational equations 161–180 radiation doses to family and
mono- and multi-exponential other individuals 65, 66
effective dose and dose rate Peptide therapy 68–69
148, 150–153 Permanent implantation 86, 87
mono- and multi-exponential illustrative example, prostrate
time dependent total-body 87
activity 148, 149 procedure 86, 87
tables for calculation of specific tumor sites 86, 87
release times with mono- and Personal dose equivalent [Hp(d)]
multi-exponential equations 142
and for specific irradiated Personnel monitoring 20, 21
groups 154–160 PET and PET/CT imaging 67
use of physical half-life prior to Physical radiation quantities for
patient’s first voidance or dosimetry 142
defecation 149 Protection radiation quantities for
Operational radiation quantities dosimetry 143
for dosimetry 142 “Pulsed” dose-rate facility design
Organ donation from radioactive 111–115, 126
patient 135 general considerations 111–115
radiation exposure of surgical need to evaluate irradiation plan
staff 135 for additional shielding 126
recipient radiation exposure not
limited 135 Qualified expert 14–15
Quality assurance (QA) 23, 24, 26,
Palliation of pain 69 48, 84, 96, 98–100, 108, 120, 125,
Patient care during brachytherapy 181–185
94–96 assay of activity 84
during treatment 94, 95 brachytherapy 23
source removal 95, 96 gamma cameras 48

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HDR anatomical source location Radiation oncologist 21, 22


108 duties 21, 22
HDR documentation 98, 99 qualification 21
HDR failure of source to retract Radiation physician-in-training
108 25, 26
HDR treatment specific duties 26
recommendations 99, 100 qualification 25
HDR workload estimation 125 Radiation safety committee 26
LDR remote afterloading 96 composition 26
nuclear medicine 23 duties 26
responsibility of management 26 Radiation safety officer (RSO) 15,
source preparation and storage 22, 23
120 duties 22, 23
treatment delivery 98 qualification 22
Quality assurance for high dose- Radiation safety procedures,
rate brachytherapy 181–185 specific for radiopharmaceutical
applicator checks 182 therapy 61–65
implant localization and imaging classification of radiation
182 workers 61
patient setup 184 cleanup of confinement room 64,
post-treatment checks 185 65
presence of treatment staff conditions for release 62, 63,
during treatment 185 141–160, 161–180
pretreatment review 183, 184 confinement of patients 62–64
recommendations from isolation of patients 61
equipment manufacturer and work practice 61, 62
AAPM 181 Radiation safety program 14–39,
setup accuracy 184 61–65
treatment planning 183 bioassays 20, 21, 33–35
treatment-preparation checks commitment of management to
181, 182 program 26, 27
treatment prescription 182, 183 control of patient specimens 38,
39
Radiation doses to family and control of personal exposure
other individuals 65, 66 27–30
Radiation dosimetrist 25 definitions specific to program
duties 25 and dose limits 17–19
qualification 25 description 14, 15
Radiation exposure control 26–30 dose limits and goals, basis 15,
monitoring 28 16
personnel monitoring 27 external monitoring 33
policies 27 management of radioactive
procedures 26, 27 sources: inventory, receipt and
radioactive sources 28 storage 29, 30
Radiation nurse 25 objectives 16
duties 25 personal monitoring 20, 21,
qualification 25 33–35

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qualified expert 14, 15 Radioactive patient, changes in


radiation safety officer 15 medical status (see changes in
recommended dose limits 17 medical status of the radioactive
record keeping 37, 38 patient)
specific procedure for Radioactive source management
radiopharmaceutical therapy 29, 30
61–65 inventory 29
receipt 29
training of personnel 37
storage 30
transport of patients 38, 39
Radioactive sources 29, 30
Radiation safety program, staffing inventory 29
21–26
receipt 29
medical physicist 23, 24 storage 30
nuclear-medicine technologist Radioactive waste disposal (see
24, 25 radiation safety program, waste
nuclear pharmacist 23, 24 disposal)
physician 21, 22 Radioimmunotherapy 67, 68
radiation dosimetrist 25 Radionuclides for brachytherapy
radiation nurse 25 73–76, 81–86
radiation physician-in-training beta-ray applicators 85
25, 26 experimental sources 85, 86
radiation safety committee 26 HDR therapy 84, 85
radiation safety officer 22, 23 LDR intracavity therapy 81–83
LDR permanent interstitial
radiation therapist 24, 25
therapy 83, 84
Radiation safety program, surveys
source types and properties
30–33
73–76, 81
airborne radioactivity 32, 33 Radionuclides for
ambient exposure rates 30, 31 radiopharmaceutical therapy
removable contamination 31, 32 42–45, 47
Radiation safety program, waste alpha emitters 45
disposal 35–37 alpha-emitting radionuclides 47
definition 35 beta emitters 42, 44
disposal to sanitary sewer 36, 37 chemical homologs of
return to vendor 35 radiopharmaceuticals labeled
storage for decay 35, 36 with photon emitters when
transfer to licensed facility 36 surrogates not available 44
commonly used radionuclides
Radiation surveys 30–33
and compounds 46
airborne radioactivity 32, 33
criteria for choice 42
ambient exposure rates 30, 31
photon emitters as surrogates for
removable contamination 31, 32 pure beta emitters for imaging
Radiation therapist 24, 25 purposes 42, 44
duties 24, 25 physical properties 43
qualification 24, 25 Radionuclide therapy 2, 3, 5–7,
Radiation weighting factor (wR) 9–13
143 brachytherapy, principles 10–12

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brief history 5–7 Radiopharmaceutical dispensing


general considerations 12, 13 laboratory 127, 128
patient confinement 2–3 certified fume hood 127
patient records 3 diagnostic and therapeutic
radiopharmaceutical therapy, applications 127
principles 9, 10 local shielding 127
research with radioactivity 7–9 practices and procedures for
Radionuclide therapy, protecting workers 127, 128
administered activity 49–55 Radiopharmaceutical facility
accuracy and traceability 51 design (see facility design,
accuracy of the administered radiopharmaceutical)
activity 52, 53 Radiopharmaceutical therapy
administration 53–55 40–70
assay of activity 50–52 administration of
basis for quantity to be radiopharmaceuticals 53–56
administered 49, 50 avoidance of pregnancy after
person responsible for therapy 60
administration 50, 52 choice of radionuclides 42–45
photon measurements with dose clinical requirements for therapy
calibrator 50, 51 program 45–60
pure beta and alpha considerations for female
measurements 51 patients 57–59
units 49 definition 40
use of a qualified expert 51 heritable effects from fetal
Radionuclide therapy facility exposure 59, 60
design, general considerations photon-emitting surrogates and
111–115 homologs for pure beta
advice of qualified expert 113, emitters 42, 44
114 physical properties of
controlled areas 111, 112 radionuclides 43, 47
designation of radiation workers systemic versus regional
113, 114 therapies 41, 42
dose limits for controlled areas Radiopharmaceutical therapy,
112, 113 emerging applications 67–70
dose limits for uncontrolled current dose prescription 67
areas 113 increasing use of PET and
requirements for patient areas PET/CT for imaging 67
114, 115 palliation of pain 69
uncontrolled areas 112 peptide therapy 68, 69
Radionuclide therapy, radioimmunotherapy 67, 68
instrumentation 47, 48 user of microspheres 69, 70
imaging 47 Radiopharmaceutical therapy,
in vitro 48 principles 9, 10, 12, 13
in vivo 47, 48 general considerations 12, 13
Radiopharmaceutical, definition Readmission, brachytherapy
18 103–106

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applicable radiation safety documentation requirements 195


procedures 105, 106 location of treatment within
procedures for handling patient shielded area 190
104 occupancy factor 188
seed inventory control 105 performance assessment 194,
Readmission of patients to the 195
treating institution 134 qualified experts and
evaluation by RSO 134 certification 186, 187
specification of radiation safety source type and activity 191, 192
precautions 134 use factor 187
Recommendations, expression of 5 workload 189, 190
shall and should 5 Shielding for radiopharmaceutical
Recommended dose limits 2, therapy 119, 126, 127, 129
15–19, 27, 113, 144–146 Special considerations for female
as low as reasonably achievable patients 41, 57–60
(ALARA) 15–17, 27 avoidance of pregnancy after
basis and goals 15–17 therapy 60
current values 17 collection of breast milk prior to
definition of family member 18 therapy 58
for families of patients and the discontinuance of lactation and
public 2, 19, 20 return to lactation 58
radionuclide therapy 113 heritable effects from fetal
specific objectives 16, 17 exposure 59, 60
Record keeping 37, 38 in utero fetal thyroid irradiation
important examples 38 57, 58
requirements 37, 38 menstruation 59
Release of patients 62–63, permanent discontinuance of
141–160, 161–180 lactation for 131I therapy 58, 59
Removal of patient radionuclides proof of pregnancy 57
at death 134, 135, 136 radioactivity in breast milk 41
permanent implants 136 Specification of photon source
radiopharmaceuticals 136 radiation output 76–78, 82
temporary implants 134–135
Respiratory arrest of patient 130, Tissue weighting factor (wT) 143
131 Training 15, 19, 21, 22, 23, 24, 25,
Rotational radiation geometry 27, 28, 36, 37, 38, 56, 62, 94, 95,
143, 144 97, 98, 103, 117, 128
applicable personnel 37
Shielding for brachytherapy dosimetrist 25
117–119, 120, 121, 123, 125, 126, family members 19, 23, 62
186–195 for addressable events 56, 103
Shielding for high dose-rate for procedural controls 27, 28
brachytherapy 186–195 general requirements 37
additional reports 186 HDR remote afterloading 97
assumptions for conservatively medical physicist 23
safe design 188, 189 nuclear medicine physician 21
construction inspection 191–194 nuclear medicine technologist 24

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nuclear pharmacist 23 Transmission curves for concrete


nurse 25 and lead 193, 194
organization of treatment Travel by released patients (see
delivery 98 conditions for)
patient care procedures 94, 95 Treatment delivery technology for
physician 21 brachytherapy 86–92
physician-in-training 25 high dose-rate remote
radiation safety officer 15, 22 afterloading 90, 91, 97–100
radiation safety program 38 low dose-rate remote
radiation therapist 24 afterloading 89, 90, 96, 97
receipt of radioactive shipments manual afterloading 88, 92–94
off-hours 128 permanent implants 86, 87
treatment area design 117 “pulsed” dose-rate remote
afterloading 91, 92
waste shipments 36
Transfer of patients to another
Use factor 187
healthcare facility 133, 134
meeting criteria for unrestricted
Visitation at death 138
release 133
procedure when not meeting
Waste disposal (see radiation
release criteria 133
safety programs, waste disposal)
providing patient information on Workload 189, 190
radioactivity status 132, 133

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