Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy (R01 Clinical Trial Optional)

The National Cancer Institute (NCI) is reissuing the funding opportunity "Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy" (R01) to support research that combines imaging and fluid-based (liquid biopsy) monitoring approaches during cancer treatment. This funding opportunity is designed for projects aiming to optimize the use of these technologies in evaluating treatment response and detecting treatment resistance early in cancer patients. By integrating imaging with liquid biopsy techniques, researchers are encouraged to explore how these methods can complement each other in capturing treatment response dynamics and advancing precision oncology. The NOFO encourages collaborative studies between imaging scientists, liquid biopsy experts, and clinical researchers to develop strategies that enhance monitoring precision and assess changes in tumor status with improved accuracy. Research areas of interest include, but are not limited to, understanding how liquid biopsy data correlate with imaging findings over time, determining the sensitivity thresholds where changes in one modality (e.g., imaging or liquid biopsy) can reliably predict changes in the other, and identifying tumor types or treatment scenarios that benefit most from combined monitoring approaches. Projects should prioritize real-time application and analysis in clinical settings, particularly with validated biomarkers or assays that are already advanced in development. Applications can propose studies in active cancer treatment scenarios, including monitoring first-line or second-line treatment for aggressive or recurrent cancers, provided the approach integrates both imaging and fluid-based assays. Importantly, research should focus on clinically actionable insights for guiding treatment adjustments or signaling early resistance; therefore, preclinical development of new assays or early detection in screening contexts will be deemed non-responsive. Proposals should emphasize well-defined and achievable goals, with applicants encouraged to discuss project relevance with NCI contacts prior to submission. The funding allows for a maximum project period of five years with budgets up to $500,000 in direct costs annually, reflecting the needs of the proposed project. Eligible applicants include higher education institutions, nonprofits, small businesses, and certain government entities. While foreign organizations cannot apply as primary applicants, U.S. organizations with non-U.S. components may participate. Applications must align with NIH submission guidelines, and completion of necessary registrations in eRA Commons, Grants.gov, and the System for Award Management (SAM) is required. Review criteria focus on the significance of the proposed research, innovation, approach rigor, and the qualifications of the investigative team and resources. The review will also consider factors such as statistical and power analyses to ensure clinical relevance, justifications for patient populations and trial structure, and the feasibility of completing data collection within the award period. Applications are evaluated for their potential impact in advancing combination monitoring techniques for cancer treatment and clinical decision-making. Key dates include the first submission deadline on February 5, 2025, with subsequent cycles scheduled through January 2028. Letters of intent are encouraged 30 days before the application due date, though they are not required. For more information on program specifics and submission requirements, applicants can contact NCI’s scientific or peer review representatives as listed in the NOFO.