EARLY CLINICAL TRIALS OF IMAGING AGENTS

Release Date:  December 18, 2001

NOTICE:  NOT-CA-02-010

National Cancer Institute

The Biomedical Imaging Program (BIP), Division of Cancer Diagnosis and 
Treatment (DCTD), National Cancer Institute (NCI) plans to develop 
contracts to support Phase 1 (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, 
radiopharmaceuticals, and contrast agents that are of interest to NCI.  
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:

o  to rapidly conduct clinical trials necessary to assess the safety of  
promising  imaging agents;

o  to rapidly conduct clinical trials necessary to assess the 
diagnostic imaging capabilities and preliminary efficacy of  promising 
imaging agents;

o  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;

o  to develop new scientific insights into molecular pathways and 
determinants of  the relationship of the targeted imaging agents to 
therapeutic drug response.

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.  These 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-27018-
45) is available on the web site of the Research Contracts and 
Acquisition Branch, NCI at:  
http://rcb.nci.nih.gov/appl/rfp/published_rfps.jsp with instructions 
for submission of proposals and evaluation criteria.

INQUIRIES   

For further information, contact:

Kathleen Giuliano
Contract Specialist
Treatment, Biology, and Sciences Section, RCB
Executive Plaza South
6120 Executive Blvd.
Rockville, MD  20892-7220
e-mail:  giulianok@mail.nih.gov
voice:  301-496-8620
fax:  301-402-6699

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