The Cancer Imaging Program has developed a contract supported infrastructure to
support Phase I (Safety) and Phase II (Preliminary 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 Efficacy Imaging Clinical Trials contracts create an
infrastructure 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:
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to rapidly conduct clinical trials necessary to assess the safety of promising
imaging agents;
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to rapidly conduct clinical trials necessary to assess the diagnostic imaging
capabilities and preliminary efficacy of promising imaging agents;
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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; and
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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 is on imaging agents which are found to be safe and provide
important structural, metabolic, or molecular imaging data which are important
and useful in the management of patients with cancer. These Phase I and Phase
II clinical trials 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 explore promising imaging agents, and require rapid initiation,
completion, and data reporting. These contracts support 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.
There have been two issuances of a Request for Proposals and four (4) contracts
have been awarded. The size of each trial varies depending on consultation with
the FDA for each specific agent. The typical size for each Safety trial is
approximately 10 patients. The typical size for each Preliminary Clinical
Efficacy trial is estimated to be 25 patients.
Currently Funded Safety and Preliminary Efficacy Imaging Clinical Trials
Contract Sites
Institution |
Principal Investigator |
Johns Hopkins University |
Richard Wahl, M.D. |
Virginia Commonwealth University |
Paul Jolles, M.D. |
Massachusetts General Hospital |
Ralph Weissleder, M.D., Ph.D. |
University of Washington |
Janet Eary, M.D. |
|