Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy (R01 Clinical Trial Optional) | PA 18 629

Frequently Asked Questions (FAQs)

1) What is the name of this grant opportunity?

The opportunity is titled "Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy (R01 Clinical Trial Optional)."

2) Which agency is offering this funding opportunity?

The National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), is offering this funding opportunity.

3) What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is PA 18-629.

4) What type of grant mechanism is this?

This is an NIH R01 Research Project Grant opportunity.

5) What is the central goal of this FOA?

The central goal is to support patient-focused research that deliberately integrates imaging-based tumor assessment and fluid-based tumor monitoring (often called liquid biopsy) during active cancer therapy to better characterize treatment response and/or detect the emergence of treatment resistance.

6) What kinds of monitoring approaches does this FOA focus on?

The FOA focuses on integrating two major approaches used to track cancer during treatment: (1) imaging-based assessments (including radiologic or molecular imaging approaches) and (2) fluid-based tumor monitoring (liquid biopsy assays performed on blood or other bodily fluids to detect tumor-derived signals).

7) Is this FOA looking for imaging-only or liquid biopsy-only projects?

No. The scientific emphasis is on integration of imaging and fluid-based tumor monitoring during active therapy in patients, rather than studying imaging or liquid biopsy in isolation.

8) What does "integration" mean in the context of this opportunity?

Integration means using imaging and fluid-based tumor monitoring together during cancer therapy to determine how, when, and in what combinations they should be used to best characterize treatment response and/or detect the emergence of resistance.

9) What kinds of outcomes or questions is NCI trying to address through this FOA?

The intent is to generate evidence on optimal use of each modality and how they complement each other in real clinical contexts. Example questions include how combined monitoring explains or predicts clinical response, residual disease, relapse risk, or early biologic signs that a tumor is adapting and becoming resistant.

10) Does the research have to occur during active cancer therapy?

Yes. The FOA emphasizes integration of imaging and fluid-based monitoring during active therapy in patients.

11) Are clinical trials required?

No. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose studies that do or do not include a clinical trial component, as long as the project fits the R01 scope.

12) If a project includes a clinical trial, are there additional requirements?

Yes. If a trial is included, the project must align with NIH definitions and requirements applicable to clinical trials.

13) Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizational types, including 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; tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status, with specified exclusions as noted in the opportunity); for-profit organizations (other than small businesses); and small businesses.

14) Are minority-serving institutions specifically included as eligible applicants?

Yes. The FOA explicitly lists eligible applicant categories that include Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

15) Are faith-based or community-based organizations eligible?

Yes. The FOA explicitly includes faith-based or community-based organizations as eligible applicants.

16) Are regional organizations eligible?

Yes. The FOA explicitly includes regional organizations as eligible applicants.

17) Are federal agencies eligible to apply?

Yes. The FOA lists eligible federal agencies among eligible applicant categories.

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

Yes. The FOA explicitly includes U.S. territories or possessions.

19) Can a foreign (non-U.S.) organization apply as the primary applicant?

No. Non-domestic (non-U.S.) entities (foreign organizations/institutions) are not eligible to apply.

20) Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are not eligible to apply.

21) Are any foreign activities allowed at all?

Yes. "Foreign components" are allowed as defined by the NIH Grants Policy Statement. This generally means a U.S. applicant organization may include certain justified and permitted foreign elements in the project, even though a foreign institution cannot be the applicant.

22) What is the award ceiling listed for this opportunity?

The listing provides an award ceiling of $499,999.

23) Is this a discretionary grant?

Yes. From an administrative standpoint, this is described as a discretionary grant mechanism under NIH.

24) What CFDA numbers are associated with this opportunity?

The opportunity lists CFDA numbers 93.393, 93.394, and 93.395.

25) What are the key dates provided in the listing?

The listing shows a creation date of 2018-02-05 and an original closing date of 2019-09-05.

26) What is NCI hoping will improve as a result of projects funded under this FOA?

The opportunity aims to advance practical, evidence-based approaches for combining imaging and liquid biopsy monitoring so clinicians and researchers can measure therapeutic effectiveness and recognize resistance earlier and more accurately during cancer treatment.

27) What is meant by "imaging-based assessments" in this FOA?

The FOA describes imaging-based assessments as radiologic or molecular imaging approaches used to visualize tumors and their behavior in the body.

28) What is meant by "fluid-based tumor monitoring" or "liquid biopsy" here?

The FOA describes fluid-based tumor monitoring (liquid biopsy) as assays performed on blood or other bodily fluids to detect tumor-derived signals.

29) What is an example of how a project might combine these approaches?

One example described is a monitoring strategy that pairs imaging findings with serial liquid biopsy measurements over time, then analyzes how well the combined information explains or predicts treatment response, residual disease, relapse risk, or early indications of resistance.

30) Does this opportunity focus on real-world clinical contexts?

Yes. The FOA emphasizes generating evidence about how imaging and fluid-based monitoring complement one another in real clinical contexts during active therapy in patients.