EARLY CLINICAL TRIALS OF IMAGING AGENTS RELEASE DATE: December 19, 2002 NOTICE: NOT-CA-03-006 National Cancer Institute (NCI) (http://www.nci.nih.gov/) The Biomedical Imaging Program (BIP), Division of Cancer Diagnosis and Treatment (DCTD), National Cancer Institute (NCI) plans to develop contracts to support Phase I (Safety) and Phase 2 (Preliminary Clinical Efficacy) clinical trials of promising imaging agents. These clinical trials will be used to rapidly evaluate the safety and diagnostic imaging capabilities of promising imaging probes, ligands, radio pharmaceuticals, and contrast agents that are of interest to the National Cancer Institute. The Safety and Preliminary Clinical Efficacy Imaging Clinical Trials contracts will create an infrastructure poised to rapidly evaluate molecularly-targeted imaging agents used to assess therapeutic anticancer agents on their molecular targets and determine clinically relevant correlates. The objectives of this program are: To rapidly conduct clinical trials necessary to assess the safety of promising imaging agents; To rapidly conduct clinical trials necessary to assess the diagnostic imaging capabilities and preliminary efficacy of promising imaging agents; To characterize the molecular interactions of new molecular imaging agents with their targets through biopsies, assays, and other appropriate technologies and correlate those effects with clinically relevant endpoints; To develop new scientific insights into molecular pathways and determinants of the relationship of the targeted imaging agents to therapeutic drug response. The major emphasis shall be on imaging agents, which are found to be safe and provide important structural, metabolic, or molecular imaging data, which will be important and useful in the management of patients with cancer. Phase 1 and Phase 2 clinical trials will obtain the necessary data to fulfill the Food and Drug Administration (FDA) criteria to eventually become an approved and potentially marketable imaging agent for specific imaging indications. The studies will explore promising imaging agents, and require rapid initiation, completion, and data reporting. These contracts will also require the ability to implement correlative studies validating the localization of the investigational imaging agents on their molecular target in tumors. Imaging agents may originate from investigators not affiliated with clinical sites. The detailed Request for Proposals (RFP: N01-CM-37008- 45) is available on the web site of the Research Contracts Branch, NCI website at: http://rcb.nci.nih.gov/appl/rfp/published_rfps.jsp with instructions for submission of proposals and evaluation criteria. Typical size for each Safety trial will be approximately 10 patients and the typical size for each Preliminary Clinical Efficacy trial is estimated to be 25 patients but may vary depending on consultation with the FDA for each specific agent. INQUIRIES For further information, contact: Kathleen E. Giuliano Contract Specialist National Cancer Institute Treatment, Biology and Science Section, RCB 6120 Executive Blvd., MSC 7193 Executive Plaza South Suite 6000, Rm 6052 Bethesda, MD 20892 301-435-3821 301-402-6699 Fax giuliank@mail.nih.gov
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