Opportunity Information: Apply for PAR 14 166

  • 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 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
  • This funding opportunity was created on Mar 28, 2014 and posted on Mar 28, 2014.
  • Applicants must submit their applications by Feb 9, 2017. (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: Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education State governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township governments Small businesses Special district governments County governments Native American tribal organizations (other than Federally recognized tribal governments) 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 Native American tribal governments (Federally recognized) Private institutions of higher education.
  • 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.
Apply for PAR 14 166

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Opportunity Summary:

The NIH funding opportunity PAR 14-166, titled "Early Phase Clinical Trials in Imaging and Image Guided Interventions (R01)," was a discretionary grant program designed to move promising cancer imaging and image-guided intervention ideas into early human testing. The core purpose of the announcement was to support Phase I and Phase II clinical trials that provide a preliminary look at both safety and early signs of effectiveness for imaging-related innovations. Rather than focusing on large, definitive trials, this FOA emphasized pilot-stage clinical evaluation, helping investigators generate the kind of clinical evidence needed to justify later, larger-scale validation studies.

The scope of projects supported under this FOA was broad across cancer imaging and image-guided intervention (IGI) technologies. It covered clinical testing of imaging agents, including brand-new agents as well as novel clinical uses of agents that are already known or used in standard practice. In addition to imaging agents, the announcement explicitly included evaluation of imaging systems and instrumentation, image processing approaches, quantitative imaging tools, contrast kinetic modeling methods, 3D reconstruction techniques, and other quantitative or computational approaches that can improve how tumors are detected, characterized, monitored, or treated. It also encompassed image-guided therapy and intervention methods, reflecting an interest not only in better images, but also in using imaging to guide procedures more precisely and safely.

A notable feature of the opportunity was its recognition that early clinical imaging trials often require more than just scanning patients. The FOA anticipated the need for patient monitoring and associated laboratory studies, which are frequently essential for understanding safety signals, biodistribution, pharmacokinetics, image-contrast behavior over time, and early performance characteristics of a new agent or method. In practical terms, the announcement was meant to provide the resources to run a well-controlled early phase cancer imaging study that can credibly answer questions like: Is the agent or method safe in humans at the intended dose or operating conditions, does it produce a measurable signal, does it add clinically meaningful information compared to current practice, and does it show enough promise to merit a larger trial.

The program was positioned as a stepping stone in a broader development pipeline. If an imaging or IGI approach demonstrated success in these early phase trials, the FOA framed the next steps as validation through subsequent competitive R01 funding 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. In other words, this mechanism aimed to reduce the early translational risk and provide the initial clinical data needed to compete for or justify more expansive, confirmatory studies.

Administratively, the opportunity used the NIH R01 grant mechanism and fell under NIH cancer research areas aligned with CFDA 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research). It did not require cost sharing or matching. The listed award ceiling was $250,000. The FOA was posted March 28, 2014, and the final closing date was February 9, 2017, with an archive date of March 12, 2017, meaning it is no longer open for application but remains available as a reference.

Eligibility was intentionally expansive, reflecting NIH norms for broad participation and collaboration in biomedical research. Eligible applicants included public and private institutions of higher education, nonprofits with or without 501(c)(3) status, small businesses, for-profit organizations (including those other than small businesses), state and local governments, tribal governments and tribal organizations, public housing authorities, and various school districts and special district governments. The FOA also allowed applications from non-U.S. entities and foreign institutions, as well as foreign components of U.S. organizations, consistent with NIH policy definitions. It specifically called out eligibility for a range of mission-driven and underrepresented-serving institutions, including HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations, among others.

Overall, PAR 14-166 was aimed at accelerating carefully designed, early phase cancer imaging and image-guided intervention clinical trials, including both innovative repurposing of established imaging approaches and first-in-human or early-in-human evaluation of new agents, systems, and quantitative methods. The practical intent was to help teams produce credible early clinical evidence on safety and initial efficacy so that the most promising imaging and IGI advances could progress into larger validation studies and, ultimately, broader clinical adoption.

Frequently Asked Questions (FAQs)

What is PAR 14-166?

PAR 14-166 is an NIH funding opportunity announcement titled "Early Phase Clinical Trials in Imaging and Image Guided Interventions (R01)." It was a discretionary grant program intended to support early clinical testing of cancer imaging and image-guided intervention (IGI) innovations in humans.

What was the main purpose of this funding opportunity?

The main purpose was to move promising cancer imaging and image-guided intervention ideas into early human testing by supporting Phase I and Phase II clinical trials. These trials were intended to provide preliminary evidence about safety and early signs of effectiveness, rather than serving as large, definitive validation studies.

What types of clinical trial phases were supported?

The FOA emphasized Phase I and Phase II clinical trials focused on early clinical evaluation, including initial assessment of safety and early performance or effectiveness signals for imaging-related innovations.

Was this opportunity meant for large, definitive clinical trials?

No. The FOA explicitly emphasized pilot-stage, early phase clinical evaluation rather than large, confirmatory trials. The intent was to generate credible early clinical evidence that could justify later, larger-scale validation studies.

What kinds of projects fell within the scope of PAR 14-166?

The scope was broad across cancer imaging and image-guided intervention technologies. It included clinical testing of imaging agents, imaging systems and instrumentation, image processing approaches, quantitative imaging tools, contrast kinetic modeling methods, 3D reconstruction techniques, and other quantitative or computational approaches aimed at improving tumor detection, characterization, monitoring, or treatment.

Did the FOA support research on imaging agents?

Yes. It covered clinical testing of imaging agents, including completely new agents and novel clinical uses of agents that were already known or used in standard practice.

Did the FOA include imaging systems, instrumentation, and software methods?

Yes. The announcement explicitly included evaluation of imaging systems and instrumentation, as well as image processing approaches and quantitative/computational methods (such as kinetic modeling and 3D reconstruction) that could improve imaging performance and clinical usefulness.

Did the FOA support image-guided therapy and intervention approaches?

Yes. In addition to improving imaging itself, the FOA encompassed image-guided therapy and intervention methods, reflecting an interest in using imaging to guide procedures more precisely and safely.

Did the FOA anticipate studies beyond imaging scans (like monitoring and lab work)?

Yes. The FOA recognized that early clinical imaging trials often require patient monitoring and associated laboratory studies. These activities were anticipated as important for evaluating safety, biodistribution, pharmacokinetics, image-contrast behavior over time, and other early performance characteristics.

What kinds of questions were these early phase trials expected to help answer?

The FOA was intended to support well-controlled early phase studies capable of addressing practical early clinical questions, such as whether the agent or method is safe in humans at the intended dose or operating conditions, whether it produces a measurable signal, whether it adds clinically meaningful information compared to current practice, and whether it shows enough promise to justify a larger trial.

What grant mechanism did PAR 14-166 use?

This opportunity used the NIH R01 grant mechanism.

Which NIH cancer research areas or CFDA listings were associated with this FOA?

The FOA aligned with NIH cancer research areas associated with CFDA 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research).

Was cost sharing or matching required?

No. The FOA did not require cost sharing or matching.

What was the listed award ceiling?

The listed award ceiling was $250,000.

When was PAR 14-166 posted, and when did it close?

The FOA was posted on March 28, 2014. The final closing date was February 9, 2017, and the archive date was March 12, 2017.

Is PAR 14-166 currently open for applications?

No. Based on the final closing and archive dates provided, PAR 14-166 is no longer open for application and remains available only as a reference.

Who was eligible to apply?

Eligibility was broad and included public and private institutions of higher education; nonprofits with or without 501(c)(3) status; small businesses; for-profit organizations (including those other than small businesses); state and local governments; tribal governments and tribal organizations; public housing authorities; school districts; and special district governments.

Were non-U.S. entities or foreign institutions allowed to apply?

Yes. The FOA allowed applications from non-U.S. entities and foreign institutions, as well as foreign components of U.S. organizations, consistent with NIH policy definitions.

Did the FOA specifically include underrepresented-serving and mission-driven institutions?

Yes. It explicitly called out eligibility for a range of institutions and organizations including HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations, among others.

How did NIH position this program within the broader development pipeline?

The FOA was positioned as a stepping stone to reduce early translational risk. If an approach showed success in early phase trials, the FOA described next steps such as validation through subsequent competitive R01 funding or through larger clinical trial infrastructures like SPOREs, NCI-designated Cancer Centers, and the NCI National Clinical Trials Network.

What did NIH consider a successful outcome for projects funded under this FOA?

A successful outcome, as described in the FOA context, was generating credible early clinical evidence on safety and initial effectiveness/performance so that the most promising imaging and IGI advances could progress into larger validation studies and potentially toward broader clinical adoption.

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