Image-guided Drug Delivery (R01 Clinical Trial Optional) | PAR 18 252

Frequently Asked Questions (FAQs): Image-guided Drug Delivery (R01 Clinical Trial Optional) - PAR-18-252

What is the Image-guided Drug Delivery (IGDD) funding opportunity (PAR-18-252)?

PAR-18-252 is a National Institutes of Health (NIH) discretionary grant funding opportunity that supports research to improve how drugs and biologics are delivered using medical imaging as a central tool. The goal is to use imaging actively and quantitatively to guide therapy administration and to measure, in living systems, whether a treatment reaches the intended target and produces a desired biological response.

What is the main purpose of this FOA?

The FOA aims to move beyond using imaging as a simple before-and-after snapshot. Instead, it prioritizes imaging as a real-time guide for where, when, and how therapies are administered, along with imaging-based measurement of delivery, distribution, pharmacodynamics, and treatment response in vivo.

What types of projects does this FOA emphasize?

Projects are expected to be innovative and quantitative, with a strong emphasis on in vivo measurement, monitoring, characterization, and validation of both therapeutic delivery and therapeutic effect. The FOA highlights approaches that integrate imaging directly into the delivery process, including real-time guidance, imaging-based monitoring of drug distribution and pharmacodynamics, and quantitative imaging assays that objectively measure delivery efficiency and response in living systems.

How does this FOA define "image-guided drug delivery" (IGDD)?

IGDD, in the context of this opportunity, refers to approaches where imaging is integrated into the delivery workflow. This can include using imaging during administration to guide placement or dosing, using imaging to monitor where a drug goes and how much arrives, and using quantitative imaging measurements to verify target engagement and biological response.

Is cancer the only disease area supported?

No. While the FOA notes particular interest in integrated imaging-based delivery systems for drugs or biologics in cancer, it also includes other diseases where targeted delivery and early intervention could improve outcomes.

What kinds of technologies or systems might fit under this FOA?

The FOA describes integrated, imaging-based delivery systems and related capabilities. Examples of the kinds of platforms referenced include combinations of imaging hardware or imaging agents with delivery devices, smart carriers, or other technologies that allow researchers or clinicians to see and verify where a therapeutic goes, how much arrives, how long it stays, and what it does once it reaches the target.

What grant mechanism is used for this opportunity?

This funding opportunity uses the NIH R01 mechanism, which generally supports substantial, hypothesis-driven research programs rather than small pilot projects.

Are clinical trials required under this FOA?

No. The FOA is labeled "Clinical Trial Optional," meaning an application may include a clinical trial if it is appropriate for the proposed aims, but a clinical trial is not required.

What research stages can be proposed if clinical trials are optional?

Based on the description, teams can propose work ranging from late-stage preclinical validation and quantitative assay development to early clinical feasibility studies, as long as the work is centered on imaging-enabled delivery and rigorous measurement of delivery and response.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. organizations and institutions, including:

• State, county, city, township, and special district governments
• Independent school districts
• Public and state-controlled higher education institutions
• Private higher education institutions
• Federally recognized Native American tribal governments
• Tribal organizations that are not federally recognized
• Public housing authorities/Indian housing authorities
• Nonprofits with and without 501(c)(3) status
• For-profit organizations other than small businesses
• Small businesses

Does the FOA encourage participation from specific institution types or communities?

Yes. The FOA explicitly highlights additional eligible applicant categories 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), and faith-based or community-based organizations. It also notes eligibility for eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), and U.S. territories or possessions.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The eligibility information provided explicitly includes non-domestic (non-U.S.) entities (foreign organizations).

Are U.S. territories or possessions eligible to apply?

Yes. The FOA eligibility information provided explicitly includes U.S. territories or possessions.

What does it mean that NIH imaging should be used as an "active, real-time guide"?

In this FOA, that phrase indicates that imaging should directly inform or guide the therapy delivery process (for example, guiding where or when a therapeutic is administered), rather than serving only as a passive assessment done before treatment begins or after treatment ends.

What is meant by "quantitative imaging assays" in this FOA?

As described, quantitative imaging assays are imaging-based measurements designed to objectively assess delivery efficiency and treatment response in living systems. The emphasis is on measurable, in vivo evaluation rather than qualitative or purely descriptive imaging outputs.

What kinds of outcomes or measurements are emphasized?

The FOA emphasizes measuring whether treatment reaches the intended target and whether it produces the desired biological response. It also highlights monitoring drug distribution and pharmacodynamics, and characterizing and validating both delivery and therapeutic effect in vivo.

Does the provided information specify an award ceiling?

No. The source information provided states that the award ceiling is not specified.

Does the provided information specify the expected number of awards?

No. The source information provided states that the expected number of awards is not specified.

Why might the award ceiling and number of awards be unspecified?

The provided description notes that this often indicates budgets and award counts may depend on NIH institute priorities, application volume, and the scope of proposed projects.

What federal funding activity categories is this opportunity associated with?

The program metadata indicates the opportunity falls under health and education-related federal funding activity categories.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.286, 93.394, and 93.395.

What are the key dates included in the provided record?

The metadata provided lists a creation date of November 30, 2017, and an original closing date of November 22, 2018.

Is this opportunity current based on the dates provided?

The record shows an original closing date of November 22, 2018, which indicates the provided listing is historical. The dates may still be useful for locating archived NIH materials or identifying successor announcements.