Title:
Quick-Trials for Imaging and Image Guided Interventions: Exploratory Grants
Contact:
Lalitha K. Shankar, MD, Ph.D.
Medical Officer
Cancer Imaging Program
National Cancer Institute
6130 Executive Blvd., Room 6048, MSC 7412
Bethesda, MD 20892-7412
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-9531; Fax: 301-480-3507
E-mail: kruegerk@mail.nih.gov
Keyvan Farahani, Ph.D. (for IGI trials)
Program Director
Cancer Imaging Program
National Cancer Institute
6130 Executive Blvd., Room 6048, MSC 7412
Bethesda, MD 20892-7412
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-9531; Fax: 301-480-3507
Email : farahank@mail.nih.gov
Objective of Project:
Imaging methodologies play a pivotal role in cancer care by providing the ability to detect tumors early and to guide therapy as well as subsequent monitoring and surveillance. Continued progress in research and development of imaging agents, methodologies, and technologies holds promise for better cancer care (i.e., improved tumor detection and characterization.) These new agents and approaches exploit various pathophysiologic and anatomic characteristics of tumors with evaluations of phenomena such as metabolism, proliferation, hypoxia, angiogenesis, essential signal pathway blockage(s), and other tumor microenvironment modifications. For example, the use of validated molecular imaging agents will be critical to the NCI drug discovery and development process as well as the ongoing NCI commitment to the biologic understanding, as well as the assessment of molecularly targeted therapeutic interventions in patients with cancer. The new Image Guide Intervention (IGI) approaches include high-intensity focused ultrasound and laser and radiofrequency ablation, among others. Rapid translation of promising discoveries in the fields of imaging probes, methodologies, technologies and image-guided therapies to clinical practice requires timely support. This Program Announcement (PAR) is intended to provide investigators with rapid access to support for pilot, Phase I, and Phase II cancer clinical trials as well as for patient monitoring and laboratory studies. The imaging agents, methods and image-guided interventions that prove successful in these early clinical trials can then be validated in larger studies through competitive R01 mechanisms or through clinical trials in the SPOREs, Cancer Centers, and/or Co-operative Groups.
Description of Project:
The focus of this PAR is to promote clinical trials conducting preliminary evaluation of the safety and efficacy of imaging agents, as well as assessment of imaging systems, image processing, image-guided therapy, contrast kinetic modeling, and three-dimensional (3-D) reconstruction and quantitative tools. This Quick‑Trial PA Imaging and Image Guided Interventions is modeled after the Quick Trials for Novel Cancer PA which has successfully provided a new approach in the grant application process by reducing the time from application submission to funding from nine months to six months. Features of this program include a modular budget, inclusion of the clinical protocol within the grant application, and accelerated peer review with the goal of issuing new awards within six months of receipt of the application. Inclusion of the complete clinical protocol within the human subjects section of the application will ensure proper peer review of the application. Other key features include no prerequisite for extensive preliminary data in the grant application, support for exploratory translational research studies, and rapid development and application of novel clinical imaging and image image-guided interventions in cancer-related applications. Investigators may apply for a maximum of 2 years of funding support using the exploratory or developmental (R21) grant mechanism for up to $250,000 direct costs per year.