Proof of Concept

Proof Of Concept
For
Bio-Marker for Diagnosis and in
Clinical Trails
By:
Lokesh Kancharla
M.TECH
1 Medical Imaging-BioMarker
Medical Imaging is a key tool in diagnosis, treatment monitoring and prediction of
therapeutic response of the disease. It is also a fundamental tool for guiding many minimally
invasive therapeutic procedures.
Any characteristic of a tissue that can be objectively measured and that represents a
parameter of its biological, functional or structural organization.
An imaging bio-marker is any parameter obtained with standard and advanced techniques to
explode, quantify and represent a tissue specific property.
These properties are hidden parameters (structural, physiological, functional, cellular,
biochemical) that can be extracted after applying to the acquired images different computational
models and specific statistical processing.
The parametric maps represent the spatial distribution in the analyzed tissue. In these
synthetic images, the pixel signal is proportional to the magnitude of the bio marker or change.
Technical Proposal - Strictly Confidential Page 1

2.Bio-Markers in Clinical Trials
Conducting a clinical trial in oncology is a major investment of both time and money, with pharmaceutical
companies spending nearly 10 years and $1.4 billion ($2.6 billion if capital costs are taken into account) to
develop a new prescription drug.
In oncology, therapeutic benefit is typically assessed by measuring tumor size and growth in response to
treatment, and is monitored through various medical imaging modalities.
Imaging is a powerful tool for visualizing cancer, but it must be performed quantitatively using
appropriate response criteria in order to generate data that are comparable among trials.
In addition, imagings complex and variable nature can produce unreliable results if standardization
practices are not implemented and carefully followed. A thorough understanding of quantitative imaging,
its potential for variability, and the standardization guidelines necessary to produce data that reliability
detects drug treatment effects are key to running a successful imaging trial in oncology.
3. Quantitative Imaging Techniques
The most commonly used quantitative imaging techniques for example oncology trials are standard CT
and MRI, which can be used to measure lesion size, detect the appearance of new lesions, and provide
anatomical information (i.e., tumor localization and structural evaluation). These modalities offer ease of
use and are widely available at clinical trial sites.

4.Our Proposed Solution:
Proof of concept Proof of Mechanism

Image Acquisition
Image Preparation
Image Processing
Measurement
Figure 1: Bio-Marker Block Diagram

Proof of Concept:
Several morphological and functional abnormalities have been reported in patients
suffering from psychiatric and neurodegenerative disorders. Neurobiological
mechanisms are difficult to understand by interpreting functional and structural
data separately. Both functional and neuronal density abnormalities may coexist in schizophrenic
patients in specific regions
Proof Of mechanism:
Demonstrate the interrelationship between the bio-marker and the concept, focusing on the effect (in
magnitude and direction) that a specific disease or a treatment have on the bio-marker.
Image Acquisition:
Appropriate images are essential for the extraction of useful bio markers. Irrespective of the technique
used(radiography, ultrasound, CT, MRI,SPECT or PET).
Image Preparation:
Prior to the analysis and modeling of the signals, images must be processed making sure that the acquired
data are optimal for the analysis
Image Processing:
Quatificatin of anatomical structures I.e. blood cells, tumors,bones structures etc., using image
segmentation techniques.
Measurement:
Parametric images, both conventional and multivariate, provide measurements from either the whole
tissue or organ being studied or only from those areas considered more representative or abnormal.

Proof of Concept - Bio-Marker

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Medical Imaging is a key tool in diagnosis, treatment monitoring and prediction of

invasive therapeutic procedures.

parameter of its biological, functional or structural organization.

explode, quantify and represent a tissue specific property.

These properties are hidden parameters (structural, physiological, functional, cellular,

models and specific statistical processing.

Technical Proposal - Strictly Confidential Page 1

3. Quantitative Imaging Techniques

Technical Proposal - Strictly Confidential Page 2

Proof of concept Proof of Mechanism

Figure 1: Bio-Marker Block Diagram

Technical Proposal - Strictly Confidential Page 3

suffering from psychiatric and neurodegenerative disorders. Neurobiological

mechanisms are difficult to understand by interpreting functional and structural

patients in specific regions

Technical Proposal - Strictly Confidential Page 4

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