Opportunity Information: Apply for PAR 18 919
The NIH funding opportunity "Quantitative Imaging Tools and Methods for Cancer Response Assessment (R01 Clinical Trial Optional)" (PAR-18-919) is designed to push proven quantitative imaging software from the development stage into real-world clinical use, specifically in the context of cancer therapy assessment and radiation therapy planning. The emphasis is not on inventing brand-new tools from scratch, but on clinically translating software that has already been built and optimized, either through the Quantitative Imaging Network (QIN) or through other prior funding. In practical terms, the program targets imaging-based software that can objectively measure or predict how a cancer is responding to treatment, as well as tools that help plan and validate radiation therapy strategies that are being tested in clinical trials.
A key requirement is that the proposed project must be a clear extension of prior successful work where the core tool or method has already been developed and tuned for performance. This FOA is essentially a bridge from "it works in the lab or in a limited setting" to "it works reliably across real clinical sites with different scanners, staff, and workflows." The funding is meant to support rigorous validation of these tools in prospective, multisite clinical trials or similar multicenter clinical settings, where performance can be tested under conditions that reflect everyday clinical variability. A major goal is to demonstrate that the tool can be integrated into clinical workflow with minimal disruption, meaning it should be practical for clinicians and trial teams to adopt without major additional burden, extensive manual intervention, or unrealistic infrastructure changes.
From a study design perspective, the FOA supports work that tests software tool performance in a way that is meaningful for clinical decision-making during trials. That typically implies attention to reproducibility, standardization across sites, robustness to different imaging acquisition conditions, and well-defined endpoints that show the tool adds value for assessing response to therapy or guiding radiation treatment strategies. Although the title notes "Clinical Trial Optional," the description strongly centers on prospective multisite validation in clinical trial-like environments, with the intent that results will be convincing enough to support broader adoption in oncology trials and potentially routine care.
The opportunity is offered as an R01 grant mechanism under the NIH, within the health and education activity category, and is associated with CFDA numbers 93.394 and 93.395. The listed award ceiling is $500,000. Eligibility is broad and includes a wide range of applicant organizations: state, county, city, township, and 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, US territories or possessions, and even non-US (foreign) organizations.
In short, this grant is aimed at research teams that already have a mature quantitative imaging software tool and are ready to prove, in a rigorous and clinically realistic multisite setting, that the tool delivers reliable, actionable information about cancer treatment response or supports radiation therapy trial planning and validation, while fitting smoothly into clinical workflows.Apply for PAR 18 919
- 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 (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, 93.395.
- This funding opportunity was created on 2018-09-12.
- Applicants must submit their applications by 2020-05-07. (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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FAQs: NIH PAR-18-919 - Quantitative Imaging Tools and Methods for Cancer Response Assessment (R01 Clinical Trial Optional)
What is this funding opportunity trying to accomplish?
This NIH R01 funding opportunity (PAR-18-919) supports the clinical translation of proven quantitative imaging software into real-world clinical use for cancer therapy assessment and radiation therapy planning/validation. The focus is on moving an already-developed tool from limited or controlled settings into routine, reliable use across multiple clinical sites.
Is this grant meant for inventing brand-new imaging tools?
No. The emphasis is not on creating brand-new quantitative imaging tools from scratch. It is intended to support tools and methods that have already been developed and optimized, and now need rigorous validation and workflow integration in clinically realistic environments.
What kinds of tools are in scope for this FOA?
The program targets imaging-based software that can objectively measure or predict how a cancer is responding to treatment, as well as software tools that help plan and validate radiation therapy strategies being tested in clinical trials.
What is the expected maturity level of the software at the time of application?
The proposed project must be a clear extension of prior successful work where the core tool or method has already been developed and tuned for performance. The FOA is positioned as a bridge from "works in the lab or limited setting" to "works reliably across real clinical sites."
Does the tool have to come from the Quantitative Imaging Network (QIN)?
No. Tools may be ones developed and optimized through the Quantitative Imaging Network (QIN) or through other prior funding. The key point is that the tool is already built and optimized, and the proposed work extends that prior success into broader clinical validation and adoption.
What type of validation does NIH appear to be looking for?
The FOA emphasizes rigorous validation in prospective, multisite clinical trials or similar multicenter clinical settings. The intent is to test performance under everyday clinical variability across sites (different scanners, staff, and workflows) and produce evidence strong enough to support adoption in oncology trials and potentially routine care.
Is a clinical trial required since the title says "Clinical Trial Optional"?
The title indicates "Clinical Trial Optional," but the description strongly centers on prospective, multisite validation in clinical trial-like environments. The overall intent is to generate clinically convincing evidence of performance and practicality, typically in multicenter settings aligned with clinical trial workflows.
Why is multisite or multicenter testing emphasized?
The purpose is to demonstrate the software works reliably across real clinical sites and conditions, not just in a single controlled environment. Multisite validation helps address clinical variability (such as scanner differences and workflow differences) and supports broader confidence and adoption.
What clinical and technical issues should the study design address?
Supported work typically needs to be meaningful for clinical decision-making during trials and therefore tends to emphasize reproducibility, standardization across sites, robustness to different imaging acquisition conditions, and well-defined endpoints showing the tool adds value for assessing therapy response or guiding radiation treatment strategies.
What does "integrated into clinical workflow with minimal disruption" mean in this FOA?
The project should show the tool can be used in clinical environments without major disruption to existing workflows. The FOA highlights adoption with minimal additional burden, limited need for extensive manual intervention, and no unrealistic requirements for new infrastructure or major workflow changes.
What grant mechanism is used for this opportunity?
This opportunity uses the NIH R01 research project grant mechanism.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $500,000.
Which activity category is associated with this opportunity?
The opportunity is within the health and education activity category.
What CFDA numbers are associated with this funding opportunity?
The opportunity is associated with CFDA numbers 93.394 and 93.395.
Who is eligible to apply?
Eligibility is broad and includes many types of organizations, including:
- State, county, city, township, and 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 and other tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with or without 501(c)(3) status
- For-profit organizations (other than small businesses) and small businesses
- Other entities
Are minority-serving institutions and community-based organizations eligible?
Yes. The FOA explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, and faith-based or community-based organizations.
Can federal agencies apply?
Yes. The FOA lists eligible federal agencies among the explicitly highlighted eligible applicants.
Can organizations outside the United States apply?
Yes. The FOA explicitly includes non-US (foreign) organizations as eligible applicants, and also highlights eligibility for US territories or possessions.
What kinds of outcomes or endpoints are implied to be important?
The FOA points toward endpoints that demonstrate the software adds value for assessing response to therapy or guiding radiation treatment strategies, in ways that matter for clinical decision-making. It also stresses performance measures tied to reproducibility, standardization, and robustness across sites.
What is the main "bridge" this FOA is funding?
It funds the transition from an imaging software tool that is already built and optimized to one that is validated prospectively across multiple clinical sites, is robust to real-world variability, and can be integrated into clinical workflows in a practical way.
What is the overarching goal for adoption?
The stated intent is for validation results to be convincing enough to support broader adoption in oncology clinical trials and potentially in routine clinical care.
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