U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 07/31/08

MAJOR ONGOING INITIATIVES

Clinical Trial Support

Image Response Assessment Teams

CIP continues to manage the Image Response Assessment Team (IRAT) program with the Association of American Cancer Institutes (AACI) as the coordinating center. In 2007, the IRATs completed their third and last year of funding. The primary goal of IRATs has been to promote functional and molecular imaging endpoints in therapy trials. IRATs are members of cancer center programs or participate in Specialized Programs of Research Excellence (SPORE) grants. Once imaging protocols are approved, the IRATs have taken responsibility for analysis, interpretation, and integration of data. Over the course of the first 2 years of support, IRATs have facilitated standardization and adoption of specific protocols.

IRAT institutions and their IRAT principal investigators
Arizona Cancer Center
Robert Gillies, Ph.D.
Holden Comprehensive Cancer Center, University of Iowa
Michael Graham, M.D., Ph.D.
Memorial Sloan-Kettering Cancer Center
Lawrence Schwartz, M.D.
Ohio State University Comprehensive Cancer Center, James Cancer Hospital & Solove Research Institute
Michael Knopp, M.D., Ph.D.
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Richard Wahl, M.D.
Siteman Cancer Center of Barnes Jewish Hospital Washington University School of Medicine
Barry Siegel, M.D.
UC Davis Cancer Center, The University of California
John Boone, Ph.D.
University of Pittsburgh Cancer Institute
James Mountz, M.D., Ph.D.

The IRATs have made progress in advancing solutions to qualitative and quantitative imaging analysis in the context of physiologic and anatomic properties inherent in images. They have also coordinated acquisition and use of phantoms to advance image instrument calibration and quality assurance of images useful as biomarkers in therapy trials.

Virtual Imaging Evaluation Workspace

Started in 2007 as joint effort between CIP and the Cancer Therapy Evaluation Program (CTEP), the Virtual Imaging Evaluation Workspace (VIEW) establishes a technical infrastructure to permit timely collection of images and relevant patient information from cancer therapy clinical trials. This 3-year program will broadly enable expert independent review of these images for large clinical trials upon request. Central image collection and analysis may be necessary when clinical images play a key role in trial result validity—such as protocol-defined primary or secondary endpoints of progression-free survival or time to progression or when imaging data are utilized for decision making in trials that include therapeutic crossover or Bayesian designs. The expert independent reads will generate quantitative, semi-quantitative, or qualitative data as prespecified by an image charter agreed to by the Food and Drug Administration (FDA) and included in the trial protocol document.

This infrastructure provides image collection processes that may also be requested for phase I and phase II trials, non-therapeutic trials, or non-FDA relevant trials, where sponsors—NCI/CTEP or otherwise—deem it necessary or desirable.