The Cancer Imaging Program (CIP), 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: 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 agent 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. 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 Government anticipates that five (5) contracts will be awarded on an incrementally funded basis for five years. The size of each trial might vary depending on consultation with the FDA for each specific agent. The typical size for each Safety trail will be approximately 10 patients. The typical size for each Preliminary Clinical Efficacy trail is estimated to be 25 patients. NAICS Code No. 621512 with a size standard of $5.Million.

Point of Contact
Kathy Giuliano, Contract Specialist,
Phone (301) 435-3821,
Fax (301) 402-6699,
Email: kg109o@nih.gov

MaryAnne Golling, Contracting Officer,
Phone (301) 435-3819,
Fax (301) 402-6699,
Email: mg345x@nih.gov

See full description: RFP: N01-CM-37008