The progress and promise of molecular imaging probes in oncologic drug development

Gary J. Kelloff, Kenneth Krohn, Steven M. Larson, Ralph Weissleder, David A. Mankoff, John M. Hoffman, Jeanne Link, Kathryn Z. Guyton, William C. Eckelman, Howard I. Scher, Joyce O'Shaughnessy, Bruce D. Cheson, Caroline C. Sigman, James L. Tatum, George Q. Mills, Daniel C. Sullivan, Janet Woodcock

Research output: Contribution to journalArticle

191 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)7967-7985
Number of pages19
JournalClinical Cancer Research
Volume11
Issue number22
DOIs
StatePublished - Nov 15 2005
Externally publishedYes

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Molecular Probes
Molecular Imaging
Biomarkers
United States Food and Drug Administration
Pharmaceutical Preparations
Drug Evaluation
Critical Pathways
Secondary Prevention
Cost-Benefit Analysis
Neoplasms
Pharmacokinetics
Apoptosis
Drug Therapy
Growth

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Kelloff, G. J., Krohn, K., Larson, S. M., Weissleder, R., Mankoff, D. A., Hoffman, J. M., ... Woodcock, J. (2005). The progress and promise of molecular imaging probes in oncologic drug development. Clinical Cancer Research, 11(22), 7967-7985. https://doi.org/10.1158/1078-0432.CCR-05-1302

The progress and promise of molecular imaging probes in oncologic drug development. / Kelloff, Gary J.; Krohn, Kenneth; Larson, Steven M.; Weissleder, Ralph; Mankoff, David A.; Hoffman, John M.; Link, Jeanne; Guyton, Kathryn Z.; Eckelman, William C.; Scher, Howard I.; O'Shaughnessy, Joyce; Cheson, Bruce D.; Sigman, Caroline C.; Tatum, James L.; Mills, George Q.; Sullivan, Daniel C.; Woodcock, Janet.

In: Clinical Cancer Research, Vol. 11, No. 22, 15.11.2005, p. 7967-7985.

Research output: Contribution to journalArticle

Kelloff, GJ, Krohn, K, Larson, SM, Weissleder, R, Mankoff, DA, Hoffman, JM, Link, J, Guyton, KZ, Eckelman, WC, Scher, HI, O'Shaughnessy, J, Cheson, BD, Sigman, CC, Tatum, JL, Mills, GQ, Sullivan, DC & Woodcock, J 2005, 'The progress and promise of molecular imaging probes in oncologic drug development', Clinical Cancer Research, vol. 11, no. 22, pp. 7967-7985. https://doi.org/10.1158/1078-0432.CCR-05-1302
Kelloff, Gary J. ; Krohn, Kenneth ; Larson, Steven M. ; Weissleder, Ralph ; Mankoff, David A. ; Hoffman, John M. ; Link, Jeanne ; Guyton, Kathryn Z. ; Eckelman, William C. ; Scher, Howard I. ; O'Shaughnessy, Joyce ; Cheson, Bruce D. ; Sigman, Caroline C. ; Tatum, James L. ; Mills, George Q. ; Sullivan, Daniel C. ; Woodcock, Janet. / The progress and promise of molecular imaging probes in oncologic drug development. In: Clinical Cancer Research. 2005 ; Vol. 11, No. 22. pp. 7967-7985.
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