Quantitative Imaging Tools and Methods for Cancer Therapy Response Assessment (UG3/UH3 Clinical Trial Optional) | PAR 18 248

FAQs: NIH PAR-18-248 - Quantitative Imaging Tools and Methods for Cancer Therapy Response Assessment (UG3/UH3 Clinical Trial Optional)

What is the NIH funding opportunity PAR-18-248 about?

PAR-18-248 is an NIH cooperative agreement opportunity that supports projects developing and validating quantitative imaging (QI) tools and methods to assess cancer therapy response. The focus is on making treatment assessment more objective, reproducible, and clinically useful by moving beyond purely qualitative or reader-dependent interpretations of medical images.

What types of outcomes or deliverables is NIH looking for?

The opportunity is aimed at producing a validated quantitative imaging capability that can be trusted to measure or predict cancer therapy response, or to strengthen radiotherapy planning and validation. The expectation is that proposed technology goes beyond a conceptual algorithm and is developed, optimized, and validated to demonstrate reliability, accuracy, and usefulness in clinical research environments.

Why does the FOA emphasize quantitative imaging instead of qualitative reads?

The FOA highlights the need to reduce subjectivity and variability that can come from human interpretation alone. Quantitative tools and analytical methods are intended to produce consistent, reproducible measurements or predictions that hold up across readers and settings, especially when used as endpoints in clinical trials.

How is this opportunity connected to clinical trials?

A major emphasis is on work relevant to clinical trials, where consistent and validated imaging endpoints can directly affect how therapies are evaluated and compared. Even when a project does not run a clinical trial, the tools and methods are expected to be designed with strong clinical translation in mind and aligned with realistic trial workflows (including multi-site use when appropriate).

What does "Clinical Trial Optional" mean here?

"Clinical Trial Optional" means a clinical trial is not mandatory for every project under this FOA. However, projects should still be designed for clinical relevance and translation, and some applicants may choose to embed development and validation within a clinical trial context when it makes sense for their approach.

What is the UG3/UH3 structure?

This FOA uses the UG3/UH3 cooperative agreement structure for phased projects. The UG3 phase is an early, milestone-driven stage focused on development and optimization. Projects may transition to the UH3 phase (later-stage support) only after meeting predefined technical and validation milestones.

What is expected during the UG3 phase?

Applicants are expected to propose a clear development and optimization plan up front. The UG3 phase is generally where that plan is executed in a milestone-driven way, with tangible progress toward a functioning quantitative imaging tool or method.

What is expected for the UH3 phase?

The UH3 phase is intended for later-stage work that proceeds once UG3 milestones are met. Based on the FOA description, the UH3 phase is where rigorous validation is emphasized, demonstrating performance in realistic settings and showing the tool is suitable for clinical research environments.

What are the two main scientific use cases targeted by this FOA?

The FOA targets quantitative imaging software tools and methodological advances supporting two broad use cases: (1) therapy response assessment, and (2) radiotherapy-focused work, including tools for radiation treatment planning strategies and methods that validate whether a radiation therapy approach is achieving intended biological or anatomical effects.

What counts as "therapy response assessment" in this FOA?

Therapy response assessment refers to methods that quantify changes in tumors or relevant tissues in ways that reflect treatment effects. The goal is to support early decision-making and/or improve endpoint sensitivity in trials by measuring response accurately over time or predicting response to therapy.

What types of radiotherapy-related projects are in scope?

Radiotherapy-related projects include quantitative imaging tools that help plan radiation treatment strategies as well as methods that can validate whether a radiotherapy approach is achieving the intended biological or anatomical effect.

Does the FOA support software tools specifically?

Yes. The FOA explicitly targets quantitative imaging software tools and methodological advances, including software and analytical methods intended to predict response or measure response accurately and reproducibly over time.

Does NIH expect purely theoretical or early conceptual algorithms?

No. The FOA emphasizes that the proposed technology should be more than a conceptual algorithm. It should be developed, optimized, and validated sufficiently to demonstrate reliability, accuracy, and usefulness in clinical research environments.

What does "validation" mean in the context of this FOA?

Validation is described as a rigorous strategy to demonstrate performance in realistic settings, ideally aligned with how imaging is collected and used in multi-site clinical trials. The intent is to show the tool is reliable, accurate, and clinically useful under real-world data and workflow pressures.

Why does the FOA mention multi-site clinical trials?

The FOA highlights multi-site trial alignment because consistent imaging endpoints across sites can impact how therapies are evaluated and compared. Tools that perform reliably across different settings are more likely to be clinically useful for trials.

What kind of award mechanism is PAR-18-248?

It is a discretionary grant opportunity offered as a cooperative agreement. Cooperative agreements generally involve more programmatic involvement from NIH staff than standard research project grants.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

What activity areas are associated with this opportunity?

The activity areas listed are education and health.

What CFDA numbers are associated with this opportunity?

The CFDA numbers associated with this opportunity are 93.394 and 93.395.

When was this opportunity created, and what closing date is shown?

The opportunity was created on 2017-11-29. The original closing date shown in the provided source listing is 2020-01-09.

Does the provided listing include an award ceiling or the expected number of awards?

No. The provided listing does not specify an award ceiling or the expected number of awards.

What types of organizations are eligible to apply?

Eligibility is broad and includes: state, county, city or 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; tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (outside higher education); for-profit organizations (other than small businesses); and small businesses.

Are minority-serving institutions and community-based organizations eligible?

Yes. The FOA explicitly calls out additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, and faith-based or community-based organizations.

Are federal agencies, U.S. territories, and regional organizations eligible?

Yes. The FOA lists eligible federal agencies, U.S. territories or possessions, and regional organizations as eligible applicant categories.

Are non-U.S. (foreign) entities eligible to apply?

Yes. The FOA explicitly includes non-U.S. (foreign) entities among eligible applicants.

What kinds of teams are a good fit for this opportunity?

The opportunity is aimed at teams that can combine imaging science, software engineering, and clinical relevance. The goal is to produce quantitative tools that perform well with real-world data and fit clinical trial and clinical research workflows.

What is the main reason NIH uses a milestone-driven phased approach here?

The UG3/UH3 structure is described as a way to ensure projects demonstrate tangible progress and meet defined milestones before advancing to later-stage support. This aligns with the FOA goal of producing developed and validated tools rather than purely conceptual methods.