A -- EARLY CLINICAL TRIALS OF IMAGING AGENTS

Notice Date

September 17, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Room 604, Rockville, MD, 20852

ZIP Code

20852

Solicitation Number

N01-CM-27018-45

Response Due

November 19, 2001

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

Description

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: 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. The solicitation is scheduled for electronic release on or about October 1, 2001. The RFP may be accessed through internet address http://rcb.nci.nih.gov/. It is the offeror's responsibility to monitor the above internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFEROR'S WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICIATION AND AMENDMENTS. Point of contact: Kathleen Giuliano, Contract Specialist at e-mail: giuliank@mail.nih.gov/ Fax: 301-402-6699; Telephone: 301-435-3821. No collect calls will be accepted. =20

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/RCB/N01-CM-27018-45/listing.html)

Record

Loren Data Corp. 20010919/ASOL007.HTM (D-260 SN50X8I4)