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

The National Institutes of Health (NIH), through its National Cancer Institute (NCI), has reissued its Funding Opportunity Announcement (FOA) PAR-21-290, titled *"Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy (R01 Clinical Trial Optional)"*. This initiative invites applications for research projects that aim to integrate imaging techniques and fluid-based tumor monitoring assays, such as liquid biopsies, into cancer therapy. The purpose of this integration is to improve the characterization of therapeutic responses and the detection of treatment resistance in real-time during cancer treatment. This FOA emphasizes using existing imaging and liquid biopsy methods, meaning novel technologies are not eligible under this announcement. Researchers must focus on applying these technologies to clinical trials or retrospective studies to optimize monitoring of cancer treatment. The main objective is to determine the best combinations of imaging (such as molecular or functional imaging modalities) and liquid biopsies (e.g., circulating tumor cells or DNA) for assessing how patients respond to treatment and how cancer evolves during therapy. The FOA encourages projects that study how these methods can be used in tandem to provide more precise, clinically meaningful insights into the dynamics of treatment response or resistance. The ultimate goal is to tailor cancer treatment more effectively to individual patients by providing more comprehensive monitoring tools during therapy. The program allows budgets of up to $500,000 in direct costs annually for a maximum of five years. The scope of the project should determine the requested budget. The application must provide strong justifications for both the patient population chosen and the ability to complete the study within the five-year funding period. Only clinical trials that use validated imaging and liquid biopsy methods are eligible for funding. Studies should also aim to establish correlations between imaging results and fluid-based assays using tissue-based assessments. Eligible applicants include higher education institutions, non-profits, for-profit organizations, and government entities. While foreign institutions cannot apply, foreign components of U.S.-based organizations are allowed. Projects should involve collaborations between clinical and imaging scientists, and the assays used must already be validated or in final stages of validation. Applications focusing on novel assay development, early detection, or pre-clinical work will not be considered. Applications are accepted in cycles, with standard NIH due dates for new, renewal, or resubmission applications. The final submission deadline is January 7, 2025. Applicants are required to submit their proposals via Grants.gov, and specific instructions are available in the SF424 (R&R) Application Guide. A letter of intent, while not mandatory, is encouraged to help the NIH gauge potential interest and workload. In conclusion, this FOA supports research that integrates advanced imaging and liquid biopsy techniques into clinical practice for real-time cancer monitoring during therapy. By bringing these tools together, the NCI hopes to advance personalized cancer treatment, ensuring that patient responses and resistance to therapies are detected as early as possible. Applications should be focused on clinical settings and must utilize previously validated methodologies.