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.Apply for PAR 17 167
- 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.
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FAQs: Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01) (PAR-17-167)
What is this grant opportunity?
Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01) (PAR-17-167) is a National Institutes of Health (NIH) funding opportunity that supports early, patient-centered clinical research to test and refine cancer imaging and image-guided intervention (IGI) approaches before they move into larger, definitive studies.
What is the main purpose of PAR-17-167?
The purpose is to fund early-phase clinical trials that generate preliminary evidence about safety and efficacy/performance for cancer imaging and IGI approaches. This includes studies that establish feasibility, optimize protocols, and produce early performance benchmarks needed to justify later-stage, larger validation trials.
What types of studies does this FOA emphasize?
The FOA emphasizes Phase I and Phase II style clinical trials where investigators are still proving feasibility in humans, refining procedures, ensuring data quality, monitoring patient safety, and selecting clinically meaningful early endpoints appropriate for an early-phase setting.
Is this funding limited to imaging agents, or does it include other imaging innovations?
It is not limited to imaging agents. The scientific scope is broad and includes imaging agents, imaging systems/hardware, and software-driven advances that improve how imaging is performed, analyzed, or applied to guide therapy.
Are new uses of existing imaging agents within scope?
Yes. The scope includes clinical evaluation of entirely new imaging agents as well as new uses of established imaging agents.
What kinds of imaging system or hardware projects are supported?
The FOA includes assessment of imaging systems and hardware as part of early clinical evaluation, particularly when the goal is to establish early human evidence of safety, feasibility, and performance in a patient-centered clinical setting.
What software or computational methods are included under this announcement?
The announcement explicitly includes software-driven advances such as image processing pipelines, quantitative imaging tools, contrast kinetic modeling, and three-dimensional reconstruction methods, when evaluated in early clinical trials.
Does the FOA support image-guided interventions (IGI) tied to treatment?
Yes. It explicitly supports work where imaging is integrated into treatment planning or delivery, including image-guided planning and/or image-guided execution of therapy.
What outcomes or endpoints are expected in these early-phase trials?
The emphasis is on endpoints that can credibly measure early signals of performance (including early evidence of safety and efficacy), while also addressing patient safety, data quality, and clinically meaningful measures suitable for early-phase clinical research.
Does this FOA allow supporting studies needed to interpret imaging results?
Yes. The FOA recognizes that early imaging and IGI ideas may require careful pilot evaluation in humans, including patient monitoring and supporting laboratory studies that help interpret imaging results or confirm biological correlates.
How does this FOA fit into the pathway from early development to larger validation trials?
This FOA is designed to help bridge the gap between promising preclinical or technical development and later, more resource-intensive validation. If an imaging agent, system, or method performs well in these early trials, the next step is framed as pursuing broader confirmation through competitive R01 pathways or through larger clinical trial infrastructures.
What examples of larger clinical trial infrastructures are mentioned as potential next steps?
The FOA mentions larger infrastructures such as Specialized Programs of Research Excellence (SPOREs), NCI-designated Cancer Centers, and the NCI National Clinical Trials Network as potential pathways for broader confirmation after successful early-phase results.
What funding mechanism is used?
The opportunity uses the NIH R01 funding instrument.
What is the general funding category for this opportunity?
It is categorized under education and health.
What CFDA numbers are associated with this FOA?
The source information lists CFDA numbers 93.394 and 93.395.
What is the listed award ceiling?
The source data lists an award ceiling of $250,000.
When was this opportunity created?
The opportunity was created on 2017-02-14.
What is the original closing date shown in the listing?
The original closing date listed is 2018-01-24.
How many awards are expected?
The provided fields do not specify the number of expected awards.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. and non-U.S. organizations, spanning government entities, educational institutions, nonprofits, for-profits (other than small businesses), small businesses, and additional categories described as "others."
Are state, county, and local governments eligible?
Yes. State governments, county governments, and local governments are listed as eligible applicants. Special district governments are also included.
Are higher education institutions eligible?
Yes. Independent school districts and both public/state-controlled and private institutions of higher education are included as eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments are eligible. Tribal organizations that are not federally recognized governments are also listed, and the FOA highlights tribal governments that are not federally recognized as an eligible group.
Are nonprofits eligible, including those without 501(c)(3) status?
Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (when not institutions of higher education) are included.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.
Does the FOA encourage participation from institutions serving historically underrepresented communities?
Yes. It highlights eligible applicant groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among the highlighted eligible applicant groups.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are listed among the highlighted eligible applicant groups.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included among the highlighted eligible applicant groups.
Are foreign (non-U.S.) entities eligible?
Yes. Foreign (non-U.S.) entities are explicitly listed among the highlighted eligible applicant groups.
What stage of research does this FOA target overall?
It targets the early clinical proof-building stage for cancer imaging and image-guided interventions, focusing on generating initial human evidence for safety, feasibility, and early efficacy/performance, and establishing the technical and procedural foundation for later validation and broader clinical adoption.
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