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

Opportunity Information: Apply for PAR 19 363

The National Cancer Institute (NCI), under the National Institutes of Health (NIH), released this Funding Opportunity Announcement (FOA) to support R01 research projects that bring together two major ways of tracking cancer during treatment: imaging (such as radiologic or molecular imaging approaches used in clinical care and research) and fluid-based tumor monitoring, commonly referred to as liquid biopsy (for example, assays that analyze tumor-derived material found in blood or other body fluids). The core purpose is to study how these approaches can be used together, in real patients receiving cancer therapy, to better understand and measure treatment response and to detect, characterize, or anticipate the development of therapeutic resistance. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose studies that include clinical trials, but they are not required to do so if the scientific aims can be met without a trial.

The scientific emphasis is on integration and optimization rather than simply running imaging and liquid biopsy in parallel. NCI is looking for projects that generate practical evidence about when each modality is most informative, how they complement one another, and how combined readouts can improve monitoring over the course of therapy. This includes determining the best timing and frequency of imaging and biospecimen collection, identifying which imaging measurements align with specific liquid biopsy signals, and evaluating how changes observed by one method can confirm, clarify, or resolve uncertainty from the other. A central theme is improving the characterization of what is happening biologically in the tumor while treatment is ongoing, including distinguishing true response from pseudo-progression or inflammatory effects, and recognizing early signals of resistance that might not yet be obvious on standard imaging or clinical assessment.

From a funding and administrative standpoint, this is a discretionary grant opportunity using the NIH R01 mechanism, intended for research projects rather than training or infrastructure alone. The opportunity number is PAR-19-363, and it is associated with CFDA (now often referred to as Assistance Listing) numbers 93.393, 93.394, and 93.395, which correspond to NCI research support programs. The source information lists an award ceiling of $499,999, and the FOA was created on 2019-09-05 with an original closing date of 2021-07-23, indicating the historical window shown in the provided record.

Eligibility is broad and includes many types of U.S.-based organizations that commonly apply to NIH: 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, nonprofits with or without 501(c)(3) status, and for-profit organizations (including small businesses, though the mechanism here is R01 rather than an SBIR/STTR). The FOA also explicitly highlights additional 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, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, there are clear restrictions on foreign involvement: non-U.S. entities (foreign organizations or foreign institutions) are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply as components. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, which typically means a U.S. applicant can include certain well-justified international elements of the research if they meet NIH policy requirements.

Overall, the opportunity is aimed at advancing how cancer therapy is monitored in real time by combining the strengths of imaging (often strong for anatomy, lesion-level assessment, and spatial context) with liquid biopsy approaches (often strong for capturing molecular changes, minimal residual disease signals, and evolving resistance mechanisms). NCI is essentially inviting teams to build rigorous, patient-centered studies that clarify how to use both tools together in a way that improves interpretation of treatment response and enables earlier, more accurate detection of resistance during cancer therapy.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy (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): 93.393, 93.394, 93.395.
• This funding opportunity was created on 2019-09-05.
• Applicants must submit their applications by 2021-07-23. (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 $499,999.00 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.

Apply for PAR 19 363

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