Opportunity Information: Apply for PAR 14 013
Apply for PAR 14 013
- 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 (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
- This funding opportunity was created on Mar 28, 2014 and posted on Feb 19, 2014.
- Applicants must submit their applications by Mar 28, 2014. (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 $200,000.00 in funding.
- Eligible applicants include: State governments Special district governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Independent school districts County governments City or township governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity PAR 14 013, titled "Early Phase Clinical Trials in Imaging and Image Guided Interventions (R21)," was designed to fund early, exploratory clinical trials that test new or newly applied cancer imaging approaches in humans. The core purpose of the program is to help investigators run pilot Phase I and Phase II studies that generate the first real clinical evidence about whether an imaging agent, imaging technology, or image-guided intervention looks safe, feasible, and promising enough to justify larger, confirmatory trials later on. In practical terms, it targets the gap between preclinical development or early technical feasibility work and the kind of large, expensive trials that would be pursued through an R01 or major cancer clinical trial networks.
Scientifically, the FOA emphasizes preliminary evaluation of both safety and efficacy in the context of cancer imaging and image-guided interventions. It is not limited to brand-new agents or devices; it also explicitly encourages novel uses of already known or standard clinical imaging agents and methods, as long as the proposed application is innovative and requires clinical trial evaluation. Beyond imaging agents themselves, the announcement highlights a broad range of imaging and analysis components that can be tested in early clinical settings, including imaging systems, image processing and quantitative analysis pipelines, image-guided therapy approaches, contrast kinetic modeling, 3-D reconstruction, and other quantitative tools that can improve detection, characterization, targeting, monitoring, or treatment guidance in oncology. The intention is to support projects where the key question can only be answered credibly in patients, even if the study is still small and exploratory.
Because these are early-stage clinical trials, the FOA anticipates the types of activities that tend to be essential in pilot studies but are often difficult to support without a targeted mechanism. That includes patient monitoring and related laboratory studies needed to understand safety signals, validate the imaging readout, correlate imaging findings with biological measures, and refine protocols. The overall expectation is that awardees will produce the kind of initial human data that de-risks an approach and sets up a clear next step: either a larger, more definitive trial funded through competitive R01 mechanisms or follow-on testing through established cancer research infrastructure such as Specialized Programs of Research Excellence (SPOREs), NCI-designated Cancer Centers, and the NCI National Clinical Trials Network.
Administratively, this is a discretionary NIH grant opportunity using the R21 mechanism, which generally supports early, high-impact exploratory work. The listed award ceiling in the source information is $200,000, and the opportunity specifies that there is no cost sharing or matching requirement. The program is categorized under health and education-related activities and maps to CFDA numbers 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research), reflecting its dual relevance to both diagnostic imaging and image-guided therapeutic applications.
Eligibility for PAR 14 013 was broad and included many types of U.S. and non-U.S. organizations. Eligible applicants included federal, state, county, city, and special district governments; public and private institutions of higher education; nonprofit organizations with and without 501(c)(3) status; small businesses and other for-profit entities; independent school districts; public housing authorities/Indian housing authorities; and tribal governments and tribal organizations. The FOA also explicitly included a range of mission-focused institutions and organizations 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 and Native American Pacific Islander-serving institutions. Foreign organizations and foreign institutions were eligible to apply, and foreign components of U.S. organizations were allowed consistent with NIH policy, which is notable for international collaborations in imaging technology and agent development.
In terms of timing, the opportunity was posted on February 19, 2014, with an original closing date of February 9, 2017, and it was later archived (archive date listed as April 28, 2014 in the provided record). The administering agency is the National Institutes of Health, and the full announcement was made available through the NIH Grants Guide (link provided in the source data). For access or technical issues, the FOA directs applicants to the NIH Office of Extramural Research (OER) webmaster contact listed in the record.
Overall, PAR 14 013 aimed to move promising cancer imaging and image-guided intervention concepts into the clinic quickly and responsibly by funding the first rounds of human testing. The program was structured to help teams demonstrate early clinical value and readiness for scale, producing the safety, feasibility, and preliminary performance evidence needed to compete for larger NIH awards or to transition into broader cancer clinical trial ecosystems.
FAQs: NIH PAR-14-013 - Early Phase Clinical Trials in Imaging and Image Guided Interventions (R21)
What is PAR-14-013?
PAR-14-013 is an NIH funding opportunity titled "Early Phase Clinical Trials in Imaging and Image Guided Interventions (R21)." It was created to support early, exploratory clinical trials in humans focused on cancer imaging and image-guided interventions.
What is the main goal of this funding opportunity?
The goal is to help investigators run pilot Phase I and Phase II clinical studies that produce initial human evidence on whether an imaging agent, imaging technology, or image-guided intervention appears safe, feasible, and promising enough to justify larger, confirmatory trials later.
What types of studies does this program support?
The program supports early-stage clinical trials, specifically pilot Phase I and Phase II efforts, designed to generate first-in-human or early clinical evidence in oncology imaging or image-guided interventions.
Is this opportunity focused only on brand-new imaging agents or devices?
No. It is not limited to entirely new agents or devices. It explicitly encourages innovative new uses of already known or standard clinical imaging agents and methods, as long as the application is novel and requires clinical trial evaluation.
What kinds of technologies or components can be evaluated under this FOA?
The FOA highlights a broad range of cancer imaging and analysis components that can be tested in early clinical settings. Examples include imaging agents, imaging systems, image processing and quantitative analysis pipelines, image-guided therapy approaches, contrast kinetic modeling, 3-D reconstruction, and other quantitative tools intended to improve detection, characterization, targeting, monitoring, or treatment guidance in oncology.
Why does the FOA emphasize testing in patients?
The intention is to support projects where the key question can only be answered credibly in patients, even if the study is still small and exploratory. In other words, the program targets the step where early human data is needed to reduce risk and clarify whether scaling up is justified.
What is meant by "early, exploratory" clinical evidence in this context?
In this FOA, early evidence generally means preliminary evaluation of safety and efficacy (or performance) for an imaging agent, imaging approach, or image-guided intervention in a clinical setting. The goal is to produce initial human data that informs whether a larger trial is warranted.
What gap is this funding intended to fill?
It is designed to fill the gap between preclinical development or early technical feasibility work and larger, expensive confirmatory studies that might be pursued via an R01 or through major cancer clinical trial networks.
Does the FOA support activities like patient monitoring and related laboratory studies?
Yes. Because these are early-stage clinical trials, the FOA anticipates that pilot studies may require patient monitoring and related laboratory studies to understand safety signals, validate imaging readouts, correlate imaging findings with biological measures, and refine clinical protocols.
What outcomes are expected at the end of an award?
The expectation is that awardees will generate initial human data that de-risks an approach and defines a clear next step, such as pursuing a larger, more definitive trial through competitive R01 mechanisms or transitioning into broader testing through established cancer research infrastructure.
What follow-on pathways are mentioned for successful projects?
The FOA points toward follow-on testing and scale-up through mechanisms and infrastructures such as R01 awards, Specialized Programs of Research Excellence (SPOREs), NCI-designated Cancer Centers, and the NCI National Clinical Trials Network.
What NIH grant mechanism is used for PAR-14-013?
This opportunity uses the NIH R21 mechanism, which is generally intended to support early, high-impact exploratory work.
What is the listed award ceiling for this opportunity?
The listed award ceiling in the provided information is $200,000.
Is cost sharing or matching required?
No. The opportunity specifies that there is no cost sharing or matching requirement.
Which agency administers this funding opportunity?
The administering agency is the National Institutes of Health (NIH).
How is the program categorized?
It is categorized under health and education-related activities and aligns with cancer imaging and image-guided therapeutic applications.
Which CFDA numbers are associated with this FOA?
The opportunity maps to CFDA 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research).
Who was eligible to apply?
Eligibility was broad and included many types of U.S. and non-U.S. organizations. Eligible applicants included federal, state, county, city, and special district governments; public and private institutions of higher education; nonprofit organizations with and without 501(c)(3) status; small businesses and other for-profit entities; independent school districts; public housing authorities/Indian housing authorities; and tribal governments and tribal organizations.
Were specific mission-focused institutions included in the eligibility list?
Yes. The FOA explicitly included institutions 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 and Native American Pacific Islander-serving institutions.
Could foreign organizations apply?
Yes. Foreign organizations and foreign institutions were eligible to apply, and foreign components of U.S. organizations were allowed consistent with NIH policy.
When was the opportunity posted?
The opportunity was posted on February 19, 2014.
What was the original closing date?
The original closing date was February 9, 2017.
Is this funding opportunity still active?
No. The provided information indicates that the opportunity was later archived (with an archive date listed as April 28, 2014 in the provided record).
Where was the full announcement made available?
The full announcement was made available through the NIH Grants Guide (as referenced in the source information).
Who should applicants contact for access or technical issues?
For access or technical issues, the FOA directs applicants to the NIH Office of Extramural Research (OER) webmaster contact listed in the record.
What general types of cancer-related applications fit this FOA?
Applications aimed at improving cancer detection, diagnosis, characterization, treatment guidance, targeting, or monitoring using imaging or image-guided approaches fit the emphasis described, particularly when early clinical trial evaluation is necessary to answer the key question.
Does the FOA focus on both diagnostic and treatment-related research?
Yes. The CFDA mappings and the described scope reflect dual relevance to cancer detection/diagnosis research and cancer treatment research, including image-guided therapeutic applications.
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