Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01 Clinical Trial Required) | PAR 18 011

Opportunity Information: Apply for PAR 18 011

Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01 Clinical Trial Required) is a National Institutes of Health funding opportunity (PAR-18-011) designed to move promising cancer imaging and image-guided intervention ideas into early clinical testing. The main purpose is to support clinical trials that generate initial human evidence about whether an imaging agent, imaging approach, or image-guided technique appears safe, workable, and potentially effective. These are meant to be the kinds of studies that help a field decide what is worth scaling up into larger, more definitive trials later.

The FOA focuses on pilot Phase I and Phase II cancer imaging clinical trials, including the practical costs that come with running early-stage trials, such as patient monitoring and associated laboratory studies. On the imaging agent side, projects can involve brand-new agents as well as new clinical uses of existing or standard imaging agents. On the technology and methods side, the announcement explicitly welcomes studies evaluating imaging systems and hardware, image processing techniques, quantitative analysis tools, contrast kinetic modeling approaches, 3-D reconstruction methods, and related quantitative pipelines. It also supports image-guided planning and/or the execution of therapy, meaning applications can include image-guided interventions where imaging is integral to targeting, guiding, or assessing a treatment procedure.

A key theme is that these studies are early in development, so the expectation is not that applicants already have large-scale, practice-changing clinical evidence. Instead, the goal is to produce credible preliminary clinical data that can justify the next step. If an imaging or IGI method performs well in these early trials, the FOA frames that success as a bridge to larger validation efforts, either through future competitive R01 submissions or through broader clinical trial infrastructures such as NCI Specialized Programs of Research Excellence (SPOREs), NCI-designated Cancer Centers, and the NCI National Clinical Trials Network.

The mechanism is an R01 grant and, as the title states, a clinical trial is required under this announcement. The activity category is listed under Education and Health, and the CFDA numbers associated with the opportunity are 93.394 and 93.395. The source information lists an award ceiling of $250,000 (as provided in the record) and indicates the opportunity was created on 2017-11-06, with an original closing date of 2020-02-14.

Eligibility is broad and includes many types of U.S.-based organizations and several categories beyond traditional academic medical centers. Eligible applicants include state, county, city/township, and 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other applicant types. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations), as well as Indian/Native American tribal governments other than federally recognized ones.

Overall, this opportunity is aimed at investigators who have a compelling imaging agent, imaging technology, quantitative imaging method, or image-guided intervention approach that is ready for early human testing in cancer, and who need R01-level support to run a Phase I or Phase II clinical trial that can establish initial safety, feasibility, and early signals of efficacy or performance. The intended end product is a strong, clinically grounded evidence base that positions the technology or method for larger trials and wider adoption pathways if results warrant it.

• 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 Clinical Trial Required)" 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 2017-11-06.
• Applicants must submit their applications by 2020-02-14. (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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