Oncology Co-Clinical Imaging Research Resources to Encourage Consensus on Quantitative Imaging Methods and Precision Medicine (U24 - Clinical Trial Optional) | PAR 18 841

Frequently Asked Questions (FAQs)

What is this funding opportunity (PAR-18-841) trying to support?

This NIH opportunity supports U24 cooperative agreements to build shared, web-accessible research resources that help the cancer imaging community reach practical agreement on how to optimize and use quantitative imaging (QI) methods in co-clinical trials. The emphasis is on methods that are tuned, standardized, and documented well enough to produce consistent, high-quality measurements that can reliably inform precision medicine.

What does "quantitative imaging (QI)" mean in the context of this FOA?

Within this FOA, quantitative imaging refers to imaging-based measurements and biomarkers that depend on clearly defined acquisition, processing, and analysis methods. The FOA frames QI as useful for precision medicine only when the underlying methods are optimized, standardized, and documented so results are accurate, reproducible, and comparable across studies.

What is the award mechanism and what does it imply?

The mechanism is a U24 cooperative agreement. A cooperative agreement typically indicates substantial NIH programmatic involvement compared to a standard grant. This aligns with the FOA focus on building community-facing resources and moving the field toward harmonized, consensus-ready approaches.

What are the main scientific goals or required components of the project?

The FOA is organized around three main goals:

1. Optimize preclinical quantitative imaging methods (protocols and analysis pipelines in animal settings) so measurements are accurate, reproducible, and fit for purpose.
2. Implement the optimized methods in an actual co-clinical trial setting (not just a technical demonstration).
3. Create an openly accessible, web-based research resource containing resulting data, methods, workflow documentation, and study outputs so others can examine, reuse, learn from, replicate, or benchmark the work.

Is the deliverable mainly publications, or something else?

Publications may result, but the FOA makes clear that a key deliverable is a durable, web-accessible resource. This implies curated datasets, protocol details, computational methods, and end-to-end workflow descriptions with enough transparency for others to understand what was done and compare approaches.

What is a "co-clinical trial" as defined by this FOA?

Co-clinical trials are coordinated investigations involving patients and, in parallel or sequentially, mouse models or human-in-mouse models of cancer that mirror the genetics and biology of the patients' malignancies or pre-cancerous lesions. The intent is to connect preclinical and clinical imaging to strengthen translational relevance.

Does the co-clinical component need a clinical aim?

Yes. The co-clinical component must have a clear clinical aim. The FOA describes potential aims such as predicting outcomes, staging disease, measuring tumor response to treatment, or supporting screening, early detection, and risk stratification (including distinguishing lethal cancers from non-lethal disease).

Are projects allowed to focus on screening and early detection, or only treatment response?

The FOA allows either. It can focus on therapeutic objectives (for example, predicting outcomes, staging, or measuring treatment response) or on screening/early detection/risk stratification, including differentiating lethal from non-lethal disease.

What does "optimize preclinical quantitative imaging methods" mean here?

It means systematically improving and characterizing imaging protocols and analysis pipelines used in animal settings so the resulting measurements are accurate, reproducible, and appropriate for their intended use. The FOA stresses that reliability depends on well-tuned and well-documented acquisition, processing, and analysis methods.

Does the FOA require using the optimized methods in a real study?

Yes. The second major goal is to implement the optimized methods in an actual co-clinical trial setting rather than keeping the work as a standalone technical validation or demonstration.

What kind of resource is expected to be built and how should it be shared?

The FOA calls for an openly accessible, web-based research resource. It should include data, methods, workflow documentation, and study outputs. The intent is that others can examine and reuse the materials, learn from the workflows, and compare approaches to move toward consensus.

What types of content are implied for the web-accessible resource?

Based on the FOA description, the resource is expected to include curated datasets, imaging protocol details, computational/analysis methods, and end-to-end workflow descriptions. It should provide enough transparency to enable replication, benchmarking, and comparison across approaches.

Why does the FOA emphasize standardization and documentation so strongly?

The FOA argues that quantitative imaging can only reliably inform precision medicine when acquisition, processing, and analysis methods are sufficiently tuned, standardized, and documented to yield consistent, high-quality measurements. Standardization and transparency are positioned as prerequisites for comparability and community consensus.

What kinds of teams are encouraged for competitive applications?

The FOA encourages multi-disciplinary teams. Competitive applications are expected to combine expertise spanning mouse model research, human clinical investigations, imaging platforms, quantitative imaging methods, decision support software, and informatics. This reflects the end-to-end nature of building consensus-ready quantitative imaging workflows.

What NIH activity category and general area does this opportunity fall under?

The opportunity is described as a discretionary NIH opportunity in the education and health activity category, focused on building shared research resources for quantitative cancer imaging in co-clinical trials.

Is this opportunity considered a clinical trial?

It is listed as clinical trial optional, based on the information provided.

What is the listed CFDA number for this opportunity?

The CFDA number listed is 93.394.

Who is the sponsoring agency?

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

What is the stated award ceiling?

The source information lists an award ceiling of $500,000.

What was the original closing date shown for this opportunity?

The original closing date shown is 2021-06-14.

Which organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations, including state, county, and local governments; special districts; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities.

Does the FOA specifically encourage applications from certain institution types?

Yes. The FOA explicitly calls out categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, faith-based or community-based organizations, regional organizations, Tribally Controlled Colleges and Universities, and U.S. territories or possessions as eligible applicant categories.

Are non-U.S. (foreign) organizations allowed to apply?

No. The FOA is explicit that non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.

Can a U.S. organization include a non-domestic component?

No. The FOA states that non-domestic components of U.S. organizations are not eligible.

Are foreign components allowed under NIH policy for this opportunity?

No. The FOA states that foreign components (as defined in NIH policy) are not allowed.

What is the overall purpose or expected impact of this FOA?

The opportunity is framed as an infrastructure-and-consensus-building program for quantitative cancer imaging in a co-clinical framework. The expected impact is improved rigor and comparability of quantitative imaging measurements used for treatment decisions or early detection, along with a publicly accessible body of data and documentation that accelerates method validation, benchmarking, and adoption.

How does this FOA aim to help the broader cancer imaging community?

By requiring transparent, web-accessible sharing of datasets, methods, and workflows, the FOA is designed to let others examine and reuse the work, compare approaches, and move toward practical agreement on best practices for quantitative imaging in co-clinical trials.