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.

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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.

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4.Our Proposed Solution:

Proof of concept Proof of Mechanism

Image Acquisition

Image Preparation

Image Processing

Measurement

Figure 1: Bio-Marker Block Diagram

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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.

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