Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01) | PAR 17 167

Opportunity Information: Apply for PAR 17 167

Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01) (PAR-17-167) is a National Institutes of Health grant opportunity designed to fund early, patient-centered clinical research that tests and refines cancer imaging and image-guided intervention approaches before they move into larger, definitive studies. The core purpose of the announcement is to support clinical trials that provide preliminary evidence about safety and efficacy, particularly for imaging agents and for technologies or methods that improve how imaging is performed, analyzed, or used to guide therapy. In practical terms, the program is aimed at the kinds of Phase I and Phase II studies where investigators are still proving feasibility, optimizing protocols, establishing early performance benchmarks, and building the evidence needed to justify broader validation in later-stage, larger-scale trials.

The scientific scope is intentionally broad across imaging and image-guided intervention (IGI) development. It includes clinical evaluation of imaging agents (including both entirely new agents and new uses of established agents), assessment of imaging systems and hardware, and testing of software-driven advances such as image processing pipelines, quantitative imaging tools, contrast kinetic modeling, and three-dimensional reconstruction methods. It also explicitly supports work where imaging is tightly integrated into treatment planning or delivery, such as image-guided planning and/or image-guided execution of therapy. The emphasis is on clinical trials that can credibly measure early signals of performance while also paying close attention to patient safety, data quality, and clinically meaningful endpoints appropriate for an early-phase setting.

A key feature of this FOA is that it recognizes many imaging and IGI ideas start out needing careful pilot evaluation in humans, including monitoring of patients and supporting laboratory studies that may be necessary to interpret imaging results or confirm biological correlates. By funding these early trials, the announcement is meant to help investigators bridge the gap between promising preclinical or technical development and later, more resource-intensive validation efforts. If an imaging agent, system, or method performs well in these early studies, the FOA frames the next step as pursuing broader confirmation through competitive R01 pathways or through larger clinical trial infrastructures such as Specialized Programs of Research Excellence (SPOREs), NCI-designated Cancer Centers, and the NCI National Clinical Trials Network.

From an administrative standpoint, the opportunity is a discretionary NIH grant mechanism using the R01 funding instrument, categorized under education and health, with CFDA numbers 93.394 and 93.395. The source data lists an award ceiling of $250,000. The opportunity was created on 2017-02-14, and the original closing date listed is 2018-01-24. While the listing does not specify the number of expected awards in the provided fields, the intent is clearly to stimulate a pipeline of early clinical imaging trials that can mature into larger, confirmatory studies.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include 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 that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (when not institutions of higher education); for-profit organizations other than small businesses; small businesses; and additional categories described as "others." The FOA also highlights additional eligible applicant groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, tribal governments that are not federally recognized, and foreign (non-U.S.) entities. This wide eligibility is meant to encourage participation from diverse institutional settings, including organizations serving historically underrepresented communities and international partners when appropriate.

Overall, this grant opportunity targets the early clinical proof-building stage for cancer imaging and image-guided interventions: generating the initial human evidence needed to demonstrate safety, feasibility, and early efficacy or performance, while establishing the technical and procedural foundation required for later validation and broader clinical adoption.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395.
• This funding opportunity was created on 2017-02-14.
• Applicants must submit their applications by 2018-01-24. (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 $250,000.00 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 17 167

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