NOT-CA-03-006: EARLY CLINICAL TRIALS OF IMAGING AGENTS

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

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
[email protected]
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