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.Apply for PAR 18 249
- 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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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Quantitative Imaging Tools and Methods for Cancer Response Assessment (U01 Clinical Trial Optional)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 18-249.
Which agency is offering this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What type of funding mechanism is this?
This opportunity uses a U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply for how the project is run?
A U01 cooperative agreement typically means NIH expects substantial programmatic involvement compared with a standard research grant.
What is the main purpose of this FOA?
The central purpose is to move mature quantitative imaging tools from development into real-world clinical trial use by supporting clinical translation and validation, especially in prospective, multisite settings.
What kinds of tools or methods is this FOA focused on?
It focuses on software-based quantitative imaging methods that can measure or predict cancer response to treatment, as well as imaging tools that support radiation therapy planning and validation within clinical trial settings.
Is this grant meant for early-stage invention or exploratory prototyping?
No. The FOA is not meant for early-stage invention or exploratory prototyping. The tools (or related data collection methods) must already be developed and optimized before the award starts.
What stage of work is this funding intended to support?
It is intended to support the clinical translation and validation phase, building directly on prior successful development work that has already achieved foundational milestones.
Does the FOA expect prior work such as participation in the Quantitative Imaging Network (QIN)?
The FOA targets tools built and refined during participation in the Quantitative Imaging Network (QIN) or through other separate funding mechanisms, and expects the proposed project to be a direct extension of that prior successful work.
What is the primary activity supported by this program?
The main activity supported is prospective, multisite clinical validation of quantitative imaging tool performance under real clinical trial conditions.
What does "prospective, multisite clinical validation" mean in the context of this FOA?
It means validating the tool in settings that resemble actual clinical trial use across multiple sites, accounting for differences such as scanners, institutions, patient populations, and operational constraints.
What aspects of tool performance are expected to be validated?
The FOA emphasizes evaluating how well the tool measures or predicts therapy response (for example, using quantitative features, longitudinal change metrics, or other imaging biomarkers) and whether results are robust and reproducible across institutions.
Does the FOA address workflow and operational feasibility in clinical trials?
Yes. A major emphasis is integration into clinical workflow, with expectations that the tool can be implemented with minimal disruption to routine trial operations.
What kinds of implementation considerations are highlighted for workflow integration?
The FOA points to practical considerations such as usability, interoperability with existing clinical systems, standardized protocols, quality control procedures, and training/support approaches that make adoption realistic in busy trial environments.
Does the FOA prioritize use within clinical trials even though it is labeled "Clinical Trial Optional"?
Yes. While labeled "Clinical Trial Optional," it clearly prioritizes validation in prospective multisite clinical trials.
What kinds of project planning are implied by the FOA's emphasis on multisite validation?
Projects will generally need a strong clinical operations plan, a clear validation strategy, and credible partnerships with trial sites capable of consistent imaging acquisition and analysis procedures.
What is the award ceiling listed in the provided information?
The award ceiling is noted as $500,000.
Does the provided information clarify whether the $500,000 ceiling is direct costs or total costs?
No. The excerpt notes the $500,000 ceiling but does not clarify whether it applies to annual direct costs or total costs.
Is the expected number of awards stated in the provided information?
No. The expected number of awards is not specified in the excerpt.
How is this opportunity categorized in the provided information?
It is categorized under discretionary funding, with activity categories listed as education and health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.394 and 93.395.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. and non-U.S. organizations, including governments, higher education institutions, nonprofits, for-profits (other than small businesses), and small businesses.
Are government entities eligible applicants?
Yes. Eligible applicants include state, county, and local governments, as well as special district governments.
Are educational institutions eligible applicants?
Yes. Eligible applicants include independent school districts and public and state-controlled institutions of higher education, as well as private institutions of higher education.
Are tribal organizations eligible to apply?
Yes. Eligible applicants include federally recognized Native American tribal governments and other tribal organizations. The FOA also highlights Tribally Controlled Colleges and Universities (TCCUs).
Are nonprofits eligible to apply?
Yes. Nonprofits with or without 501(c)(3) status are eligible in the provided list (excluding institutions of higher education within those nonprofit categories as stated in the excerpt).
Are for-profit organizations eligible to apply?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are public housing authorities eligible to apply?
Yes. Public housing authorities/Indian housing authorities are included as eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA explicitly highlights non-domestic (foreign) entities as eligible.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly highlighted as eligible applicant categories.
Does the FOA highlight specific institution types beyond general eligibility?
Yes. It explicitly highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, and regional organizations.
What problem is this FOA trying to solve for quantitative imaging tools?
It addresses the gap between a tool working well in a controlled research environment and proving it performs reliably across multiple clinical sites and fits into routine clinical trial operations without creating major workflow barriers.
What is meant by validating under "conditions that matter for clinical trials"?
It refers to testing performance across different scanners, sites, patient populations, and real operational constraints encountered during clinical trials.
When was this FOA created and what closing date is listed in the provided information?
The FOA was created on 2017-11-29, and the original closing date listed was 2018-09-13.
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| The NCI Transition Career Development Award (K22 - Independent Clinical Trial Not Allowed) Apply for PAR 18 467 Funding Number: PAR 18 467 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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