Imaging, Biomarkers and Digital Pathomics for the Early Detection of Premetastatic Cancer and Precancerous Lesions Associated with Lethal Phenotypes (R01 Clinical Trial Optional)

The Department of Health and Human Services, through the National Institutes of Health (NIH) and its National Cancer Institute (NCI), has reissued the funding opportunity announcement PAR-22-131, supporting the development of integrated technologies in imaging, biomarkers, and digital pathomics for the early detection of premetastatic cancer and precancerous lesions that are associated with lethal outcomes. This funding opportunity utilizes the NIH R01 Research Project Grant mechanism and supports projects that have already established proof-of-principle with sufficient preliminary data. It aims to address the significant clinical challenge of overdiagnosis and false positives by improving the sensitivity and specificity of cancer detection methods using multiparametric platforms and integrated analytics such as artificial intelligence and virtual reality. The overarching goal is to enable the early detection and accurate characterization of aggressive, organ-confined cancer and precancerous lesions to distinguish life-threatening from non-lethal disease. Projects must involve the integration of imaging, biomarkers, glycomics, metabolomics, and other omic data, ideally across multiple platforms and resolution levels. These integrative efforts are expected to improve clinical decision-making and outcomes in cancer detection and risk stratification. Funded projects will become part of the Consortium for Imaging and Biomarkers (CIB) Research Program, promoting collaboration, data sharing, and methodological standardization across awardees. Applications may propose combining validated diagnostic tools with experimental methodologies or explore novel imageable biomarkers. Multidisciplinary collaboration is strongly encouraged, with projects drawing from expertise in clinical oncology, biomedical engineering, molecular imaging, informatics, and related fields. While the FOA does not support the development of entirely new imaging technologies, it will fund projects applying innovative uses of existing tools to meet the FOA’s specific goals. Eligible applicants include a wide range of domestic and international entities, including institutions of higher education, nonprofits, for-profit organizations, tribal entities, and state and local governments. Applications must comply with all registration requirements, including active registrations in SAM, eRA Commons, and Grants.gov. Applicants must follow the SF424 (R&R) Application Guide and provide a comprehensive Data Management and Sharing Plan. Applications are accepted on NIH’s standard due dates, with the final application deadline set for May 24, 2025. While letters of intent are not required, applicants are encouraged to contact program officials for guidance. Scientific contacts include Drs. Sudhir Srivastava, Richard Mazurchuk, Guillermo Marquez, and Huiming Zhang. Financial questions may be directed to Amy R. Bartosch. Applications undergo peer review based on criteria including significance, investigator expertise, innovation, approach, and environment, with special emphasis on collaborative potential and translational impact.