Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy (R01 Clinical Trial Optional) | PAR 19 363

Frequently Asked Questions (FAQs)

What is the goal of this funding opportunity?

The goal is to support NIH R01 research projects that integrate cancer imaging approaches with fluid-based tumor monitoring (liquid biopsy) in patients receiving cancer therapy, in order to better measure treatment response and to detect, characterize, or anticipate therapeutic resistance as treatment is ongoing.

Which agency is offering this grant?

This Funding Opportunity Announcement (FOA) is offered by the National Cancer Institute (NCI) under the National Institutes of Health (NIH).

What is the FOA number?

The opportunity number is PAR-19-363.

What funding mechanism is used?

This opportunity uses the NIH R01 research project grant mechanism and is intended to fund research projects (not training programs or infrastructure-only efforts).

Is a clinical trial required?

No. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial, but a clinical trial is not required if the research aims can be achieved without one.

What kinds of research are emphasized?

The emphasis is on integration and optimization of imaging and liquid biopsy, not simply running them side-by-side. NCI is seeking practical evidence about when each modality is most informative, how they complement each other, and how combined readouts improve monitoring across the course of therapy.

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

Integration refers to designing studies that connect imaging readouts with liquid biopsy signals in a coordinated way, such as aligning imaging measurements with specific fluid-based tumor signals, using one modality to confirm or clarify findings from the other, and resolving uncertainty (for example, when imaging changes are difficult to interpret on their own).

What patient setting is the FOA focused on?

The FOA is focused on real patients receiving cancer therapy, with monitoring occurring during treatment to understand response and the development of resistance in real time.

What are examples of imaging approaches covered by this opportunity?

The FOA includes imaging used in clinical care and research, such as radiologic imaging and molecular imaging approaches.

What is meant by "liquid biopsy" in this opportunity?

Liquid biopsy refers to assays that analyze tumor-derived material found in blood or other body fluids to monitor cancer during treatment.

What kinds of questions should projects address about timing and frequency?

Projects are expected to generate evidence about the best timing and frequency of imaging and biospecimen collection, including when each modality provides the most informative signals during therapy and how schedules can be optimized when the approaches are used together.

How does the FOA relate to assessing treatment response?

The FOA supports research aimed at improving how treatment response is interpreted during therapy, including distinguishing true response from pseudo-progression or inflammatory effects that can complicate standard imaging interpretation.

How does the FOA address therapeutic resistance?

A central theme is recognizing early signals of resistance that may not yet be obvious on standard imaging or clinical assessment, and using combined imaging and liquid biopsy readouts to detect, characterize, or anticipate resistance as it develops.

Does the FOA encourage studies that compare how the two modalities confirm each other?

Yes. The FOA explicitly emphasizes evaluating how changes observed by one method can confirm, clarify, or resolve uncertainty from the other method.

What is the maximum award amount shown in the provided record?

The source information lists an award ceiling of $499,999.

What are the Assistance Listing (CFDA) numbers associated with this FOA?

The FOA is associated with Assistance Listing (formerly CFDA) numbers 93.393, 93.394, and 93.395, which correspond to NCI research support programs.

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

The record states the FOA was created on 2019-09-05 and shows an original closing date of 2021-07-23, indicating the historical window reflected in the provided information.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations that commonly apply to NIH, including public and private institutions of higher education, state and local governments, federally recognized tribal governments, certain tribal organizations, independent school districts, special district governments, public housing authorities/Indian housing authorities, nonprofit organizations (with or without 501(c)(3) status), and for-profit organizations (including small businesses, noting the mechanism is R01 rather than SBIR/STTR).

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

Yes. The FOA explicitly highlights eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISI), as well as faith-based or community-based organizations.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA includes U.S. territories or possessions among eligible applicant categories.

Can a foreign organization apply as the main applicant?

No. Non-U.S. entities (foreign organizations or foreign institutions) are not eligible to apply as applicant organizations under this FOA.

Can a U.S. organization include a non-U.S. (non-domestic) component as part of the application?

No. Non-domestic components of U.S. organizations are not eligible to apply as components under this FOA, based on the restrictions described in the provided information.

Are foreign components allowed at all?

Yes. The FOA allows foreign components as defined under the NIH Grants Policy Statement, which typically means a U.S. applicant may include well-justified international elements of the research if they meet NIH policy requirements.

Is this opportunity intended to fund training programs or infrastructure by itself?

No. The FOA is described as a discretionary grant opportunity using the NIH R01 mechanism, intended for research projects rather than training or infrastructure alone.

What is the overall expected impact of projects funded under this FOA?

The opportunity is aimed at advancing real-time monitoring of cancer therapy by combining the strengths of imaging (for anatomy, lesion-level assessment, and spatial context) with the strengths of liquid biopsy (for molecular changes, minimal residual disease signals, and evolving resistance mechanisms), leading to earlier and more accurate interpretation of response and resistance during treatment.