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13 April 2017

Why It’s Important to Add Volume Data to a Clinical Study

Going Beyond RECIST – Part 2

Why It’s Important to Add Volume Data to a Clinical Study

[Part 2 of our 3 Part series on Going Beyond RECIST: a look at volumetric and functional tumor analysis in oncology clinical trials.]

Capturing tumor volume data during a clinical trial can add significant value to a study. Three-dimensional measurements can be easily incorporated into existing clinical trial workflows using cloud-based automated image acquisition and management software like Median Technologies’ Lesion Management Solutions (LMS) software. The simultaneous detection of unidimensional and 3-dimensional measurements allows for the efficient analysis of both routine and advanced endpoints, providing robust evaluation and quantification of disease status. In early phase trials, the increased sensitivity of volume-based measurements provides an earlier indication of response, allowing for fast and informed “go or no go” decisions to be made.  In later phase trials, advanced imaging endpoints can be correlated to standard RECIST1.1 to assess therapeutic efficacy.

Three-dimensional, volume-based measurements address some of the inherent limitations of unidimensional RECIST measurements, provide additional measures of efficacy for modern drug classes, and allow for earlier detection of therapeutic response. Although not yet accepted as true surrogate endpoints, studies are underway to further examine the relationship between these experimental endpoints and more traditional imaging measurements, and how volume-based measurements relate to clinical outcomes. Early studies indicate that volume-based measurements are both medically meaningful and add value to a clinical trial. Volume measurements can be easily incorporated into existing clinical trial workflows using segmentation software that also improves trial efficiency and reproducibility.

However, it is important to note that they cannot substitute for RECIST in phase III approval studies in solid tumors.   As advanced imaging endpoints continue through the validation and standardization process, it is our hope that they eventually achieve surrogate endpoint status, ultimately adding to the arsenal of therapeutic response tools available to clinicians in the clinical trial setting.

Post Author:

Dr. Nathalie Faye, Medical Director, Median Technologies

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