Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R21)
(Expiration date: March 14, 2014)
Lalitha K. Shankar, M.D., Ph.D.
Frank I. Lin, M.D.
This announcement is intended to support clinical trials conducting preliminary evaluation of the safety and efficacy of imaging agents, as well as an assessment of imaging systems, image processing, image-guided therapy, contrast kinetic modeling, and 3-D reconstruction and other quantitative tools. As many such preliminary evaluations are early in development, this program will provide investigators with support for pilot (phase 1 and 2) cancer imaging clinical trials, including patient monitoring and laboratory studies. The imaging and Image-guided Intervention (IGI) investigations, if proven successful in these early clinical trials, can then be validated in larger studies through competitive R01 mechanisms, or through clinical trials in the Specialized Programs of Research Excellence (SPOREs), Cancer Centers, and/or Cooperative Groups.
Paula M. Jacobs, Ph.D., is Associate Director, Cancer Imaging Program in the Division of Cancer Treatment and Diagnosis at the National Cancer Institute. She came to work at the NCI after 30 years in the pharmaceutical and medical device industries where she was a key developer of ultrasmall superparamagnetic iron oxide drugs as magnetic resonance imaging agents and iron replacement therapeutics. More…