Quantitative Imaging Tools and Methods for Cancer Response Assessment (U01 Clinical Trial Optional) | PAR 18 249

Opportunity Information: Apply for PAR 18 249

The grant opportunity "Quantitative Imaging Tools and Methods for Cancer Response Assessment (U01 Clinical Trial Optional)" (Funding Opportunity Number PAR 18-249) is a National Institutes of Health (NIH) cooperative agreement designed to help move mature quantitative imaging tools from the development stage into real-world clinical trial use. Its central focus is on clinically translating software-based quantitative imaging methods that can measure or predict how a cancer is responding to treatment, as well as imaging tools that support radiation therapy planning and validation within clinical trial settings. In practical terms, the FOA is aimed at teams that already have a tool that works well in a controlled research environment and now need the support and structure to prove it performs reliably across multiple clinical sites and can be used as part of routine trial operations without slowing everything down or creating major workflow problems.

A key requirement is that the quantitative imaging tools (or the related data collection methods) must already be developed and optimized before this award starts. The FOA is not meant for early-stage invention or exploratory prototyping. Instead, it targets tools that were built and refined during participation in the Quantitative Imaging Network (QIN) or through other separate funding mechanisms. The proposed project is expected to be a direct extension of prior successful work, meaning applicants should be able to show that foundational development milestones have already been achieved and that what remains is the clinical translation and validation phase. The intent is to take something proven in principle and test it under the kinds of conditions that matter for clinical trials: different scanners, different sites, different patient populations, and different operational constraints.

The main activity supported by this program is prospective, multisite clinical validation. The FOA specifically emphasizes validating tool performance in settings that resemble how the tool would actually be used to support clinical decision-making during trials. This includes evaluating how well the tool measures or predicts therapy response (for example, through quantitative features, longitudinal change metrics, or other imaging biomarkers), and whether its outputs are robust enough to be trusted across institutions. Just as importantly, the program is concerned with integration into clinical workflow. Applicants are expected to demonstrate that the tool can be implemented with minimal disruption, which generally implies attention to usability, interoperability with existing clinical systems, standardized protocols, quality control procedures, and training/support approaches that make adoption realistic in busy trial environments.

The funding mechanism is a U01 cooperative agreement, which typically means NIH anticipates substantial programmatic involvement compared with a standard research grant. While the FOA is labeled "Clinical Trial Optional," it clearly prioritizes validation in prospective multisite clinical trials, so projects will generally need a strong clinical operations plan, a clear validation strategy, and credible partnerships with trial sites that can execute consistent imaging acquisition and analysis procedures. The opportunity is categorized under discretionary funding, with activity categories listed as education and health, and CFDA numbers 93.394 and 93.395.

In terms of who can apply, eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (foreign) entities, and U.S. territories or possessions. This breadth reflects an emphasis on enabling collaborations that can span technical development groups, academic medical centers, community-based clinical networks, and specialized institutions that may be well-positioned to support diverse and multisite validation.

Administrative details included in the source information indicate the NIH is the sponsoring agency, the FOA was created on 2017-11-29, and the original closing date listed was 2018-09-13. The award ceiling is noted as $500,000, suggesting an upper bound on annual direct costs or total costs depending on the FOA specifics, but the provided text does not clarify which cost basis applies. The expected number of awards is not specified in the excerpt. Overall, the opportunity is best understood as a targeted translational bridge: it funds the step where a quantitative imaging tool that is already optimized is put through rigorous, prospective, multisite clinical testing to show it is accurate, reproducible, and operationally feasible as part of real cancer therapy trials, including those involving radiation therapy planning and verification.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Quantitative Imaging Tools and Methods for Cancer Response Assessment (U01 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, 93.395.
• This funding opportunity was created on 2017-11-29.
• Applicants must submit their applications by 2018-09-13. (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.

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