Clinical Translation of Activated Optical Fluorescence Methods and Technologies for Sensitive Cancer Detection in Vivo (R01 Clinical Trial Optional) | PAR 20 295

Opportunity Information: Apply for PAR 20 295

The NIH National Cancer Institute funding opportunity PAR-20-295 (R01, Clinical Trial Optional) supports projects aimed at moving highly sensitive optical fluorescence imaging approaches into real clinical use for finding very small cancers inside the body. The central problem the program is trying to solve is that many current clinical imaging methods can reliably detect tumors once they are several millimeters to centimeters in size, but they struggle to pick up much smaller primary or metastatic sites. The FOA specifically targets the ability to visualize extremely small tumor deposits on the order of 1 to 3 mm, which correspond roughly to clusters of about 10^6 to 10^7 cells. The overarching aim is to make these small tumor cell aggregations detectable in vivo, which would strengthen early detection and improve guidance for clinical decision-making.

A key feature of this opportunity is its emphasis on improving imaging sensitivity primarily through better biological contrast rather than major new imaging hardware. The FOA highlights that sensitivity limitations can often be addressed by increasing the contrast between diseased and healthy tissue in the image. In this program, that contrast improvement is expected to come from "intelligent" or "activated" optical fluorescence agents or probes, meaning specialized fluorescent agents designed to remain relatively quiet until they interact with a tumor-associated target or tumor microenvironment trigger. When activated at the tumor site, these agents can produce a strong fluorescence signal that makes small tumor foci stand out more clearly against background tissue, allowing clinicians to see lesions that would otherwise be missed.

The NCI is looking for innovative concepts that already have demonstrated capability to detect small tumors and that can present a credible, well-structured path to clinical validation. The emphasis is not on inventing brand-new fluorescence agent concepts from scratch, but on translating existing activated fluorescence strategies that have shown promise over the past decade into clinical environments where they can be tested and validated. The announcement makes clear that clinical translation and validation are the primary goals. Limited additional development work is acceptable if it is necessary to enable clinical validation, but the bulk of the research plan is expected to focus on the practical steps of bringing the approach into clinical workflows, demonstrating performance in vivo, and generating evidence that the method can reliably visualize tumor deposits at approximately the 1 mm scale.

This is an R01 research grant mechanism, and clinical trials are optional, meaning applicants may propose studies that include clinical trial components if appropriate, but they are not required to do so. The opportunity is categorized as discretionary grant funding within education and health activities, under CFDA 93.394, and is administered by the National Institutes of Health. The listing includes an award ceiling of $500,000, with the original closing date shown as October 13, 2021, and a creation date of August 28, 2020.

Eligibility is broad and includes many types of organizations and government entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; Native American tribal governments (federally recognized); tribal organizations (including those other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories as noted); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly notes additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Overall, the opportunity is designed for teams that can bridge advanced optical molecular imaging science and real-world clinical translation, with a strong focus on proving that activated fluorescence agents can deliver clinically meaningful improvements in sensitivity for detecting very small tumors in vivo. The expected outcome is not just a promising prototype or preclinical proof-of-concept, but credible clinical validation progress demonstrating that these activated optical fluorescence methods can be used in practice to make tiny tumor deposits visible against background tissue.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Clinical Translation of Activated Optical Fluorescence Methods and Technologies for Sensitive Cancer Detection in Vivo (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
• This funding opportunity was created on 2020-08-28.
• Applicants must submit their applications by 2021-10-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 20 295

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