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Last Updated: 08/18/21

Phase I/II Trials

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:

  • 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; and
  • 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.

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.

The Experimental Therapeutics Clinical Trials Network (ETCTN) was created to develop new approaches to cancer treatment in early phase (Phase I and Phase II) experimental therapeutic clinical trials, inclusive of early clinical trials of NCI-IND agents in high priority areas of unmet medical needs. Participants collaborate with NCI staff to achieve ETCTN objectives. The NCI provides centralized support for such activities as data management, clinical trial registration, regulatory support, and Central Institutional Review Board (CIRB) review.