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Vol-PACT: Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results

Millions of dollars and thousands of patients are invested in the development and testing of new therapies for solid tumor cancers, yet a large proportion of Phase III trials fail to show significant treatment benefit. One possible explanation for these failures is that outcomes used to measure Phase II trials are inadequate, particularly in imaging solid tumors. Newer 3D imaging approaches to measuring tumor volume, such as volumetric CT, have shown promise for replacing traditional 1D and 2D techniques. Through public-private partnership, this project seeks to analyze volumetric CT imaging data from completed industry phase II solid tumor trials and develop new metrics of response to improve quantitative prediction of phase III results.

Goals

  • Assess which quantitative metrics for phase II trial analysis most accurately and reliably predict phase III results across multiple treatment regimens and cancer types.
  • Study different characteristics of objective progression and their association with improved overall survival, towards the development of improved criteria for progression.
  • Quantify the added value of volumetric tumor measurement as compared to conventional cross-sectional measurement for quantification of response and progression.
  • Study differences amongst the above analyses across different classes of systemic therapies, including immunotherapies.

MSK Project Team

  • Mithat Gonen
  • Chaya Moskowitz
  • Patrick Hilden
  • Jessica Flynn

Partners

Amgen, Inc.
AstraZeneca Pharmaceuticals LP
Bristol-Myers Squibb Company
Columbia University
Dana Farber Cancer Institute
Food and Drug Administration
GlaxoSmithKline
Johnson & Johnson
Merck Sharp & Dohme Corp.
National Cancer Institute
Pfizer Inc
Sanofi
University of Chicago
Wyeth Nutrition