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Authors' Affiliations: 1 Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH; 2 Molecular Tracer, LLC, Bethesda, Maryland; 3 Division of Nuclear Medicine, Department of Radiology, University of Washington, Seattle, Washington; 4 Memorial Sloan-Kettering Cancer Center, New York, New York; 5 Center for Molecular Imaging Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, Massachusetts; 6 CCS Associates, Mountain View, California; 7 Baylor Charles A. Sammons Cancer Center, Dallas, Texas; 8 Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia; and 9 Office of Drug Evaluation, Division of Medical Imaging and Radiopharmaceutical Drug Products, and 10 Office of the Commissioner, Food and Drug Administration, Rockville, Maryland
Requests for reprints: Gary J. Kelloff, Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, EPN 6130 Executive Boulevard, Suite 6058, Bethesda, MD 20892. Phone: 301-594-0423; Fax: 301-480-3507; E-mail: kelloffg{at}mail.nih.gov.
As addressed by the recent Food and Drug Administration Critical Path Initiative, tools are urgently needed to increase the speed, efficiency, and cost-effectiveness of drug development for cancer and other diseases. Molecular imaging probes developed based on recent scientific advances have great potential as oncologic drug development tools. Basic science studies using molecular imaging probes can help to identify and characterize disease-specific targets for oncologic drug therapy. Imaging end points, based on these disease-specific biomarkers, hold great promise to better define, stratify, and enrich study groups and to provide direct biological measures of response. Imaging-based biomarkers also have promise for speeding drug evaluation by supplementing or replacing preclinical and clinical pharmacokinetic and pharmacodynamic evaluations, including target interaction and modulation. Such analyses may be particularly valuable in early comparative studies among candidates designed to interact with the same molecular target. Finally, as response biomarkers, imaging end points that characterize tumor vitality, growth, or apoptosis can also serve as early surrogates of therapy success. This article outlines the scientific basis of oncology imaging probes and presents examples of probes that could facilitate progress. The current regulatory opportunities for new and existing probe development and testing are also reviewed, with a focus on recent Food and Drug Administration guidance to facilitate early clinical development of promising probes.
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