Quantitative Imaging for Evaluation of Responses to Cancer Therapies (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Quantitative Imaging for Evaluation of Responses to Cancer Therapies (U01) opportunity?

This opportunity (Funding Opportunity Number PAR-08-225) is an NIH cooperative agreement (U01) focused on accelerating the use of quantitative medical imaging to measure how tumors respond to cancer therapies. The goal is to move from mainly qualitative, subjective image interpretation toward standardized, reproducible imaging-based measurements that can support faster and more reliable decisions about whether a therapy is working.

What is the main purpose of this FOA?

The program is designed to develop, refine, implement, validate, and standardize quantitative imaging methods that can be used as response assessment tools in clinical trial settings. It emphasizes practical translation so imaging measurements can be compared across sites and studies and potentially used in routine clinical care.

What does "response assessment" mean in this announcement?

Response assessment refers to imaging endpoints that show treatment effects over time, such as measurable changes in tumors during or after therapy. The FOA is positioned around imaging-derived measurements of treatment response rather than discovering entirely new therapies or conducting the treatment trials themselves.

What kinds of projects are expected to be supported?

Supported projects are expected to develop, refine, or implement quantitative imaging methods and then apply them in real-world contexts tied to ongoing or planned early-stage clinical therapy trials (Phase 1 and Phase 2). The work can include protocol development, standardization of image acquisition, quality control approaches, analysis pipelines, and validation studies.

Are projects required to be linked to clinical trials?

Yes. The imaging research is intended to be used within the context of ongoing or planned early-stage clinical therapy trials (Phase 1 and Phase 2). The emphasis is on embedding quantitative imaging response methods into real clinical trial workflows.

Does this FOA fund the clinical trials themselves?

No. A key boundary of the announcement is that it does not pay for the clinical trials themselves. The grant supports the imaging methodology work that plugs into trials that are already funded or otherwise supported.

What specific imaging-related activities can the grant cover?

Based on the description provided, the grant can cover imaging methodology work such as developing and standardizing imaging protocols, harmonizing image acquisition procedures across sites, establishing quality control processes, building analysis pipelines and software tools, and performing validation efforts to demonstrate that quantitative measurements are reliable and reproducible.

What therapies are in scope for response imaging in this program?

The scientific focus must remain on imaging-derived quantitative measurements of response to drugs and/or radiation therapy. The description also indicates the scope can include image-guided interventions where imaging measurements directly inform or track an intervention.

Is the FOA intended to support new imaging hardware development?

The program emphasizes practical translation and encourages tools, protocols, and software solutions that work with existing commercial imaging platforms and instrumentation. It is positioned as an implementation-and-validation push rather than a program built around custom scanners or purely experimental hardware.

Do projects need to work with commercial imaging platforms?

Applicants are encouraged to develop approaches that align with existing commercial imaging platforms and instrumentation, with the intent of making quantitative response imaging feasible in typical clinical settings and enabling comparisons across sites and trials.

Why is standardization and reproducibility emphasized?

The FOA aims to produce validated imaging measurements that are reliable enough to be used as decision tools in trials and potentially in routine care. Standardization supports cross-site comparability, reduces variability due to scanner and protocol differences, and enables broader adoption beyond a single institution.

What is the Quantitative Imaging Network (QIN) and how does it relate to this award?

Awardees are expected to participate in the Quantitative Imaging Network (QIN), a collaborative structure where funded teams share ideas, methods, and data-handling approaches. A major goal is to validate and standardize imaging data and imaging metadata so quantitative measurements can be compared across instruments, sites, and studies.

What kinds of collaboration are expected within QIN?

The description highlights working toward harmonized acquisition protocols, common definitions of quantitative metrics, shared calibration and quality assurance procedures, and agreed-upon conventions for recording metadata that can affect measurement (such as scanner settings, reconstruction parameters, timing, and contrast use).

What does the U01 cooperative agreement mechanism imply for applicants?

A U01 cooperative agreement generally implies a closer working relationship with NIH program staff than a typical investigator-initiated grant. The description notes this often includes coordinated milestones or network-oriented expectations, consistent with participation in the QIN collaborative structure.

What kind of teams are expected to be competitive?

The FOA strongly expects multidisciplinary teams. Competitive teams would typically include oncologists (disease context and clinical endpoints), clinical imaging experts (acquisition realities and workflow), and basic or quantitative imaging scientists (algorithms, biomarkers, and validation frameworks).

Are industrial partners required?

No. Industrial partner involvement is not required, but it is strongly encouraged. The rationale given is to align methods with commercial platforms, software ecosystems, and practical implementation pathways that can extend beyond a single lab or institution.

What is the intended outcome of projects funded under this FOA?

The practical outcome NIH is pushing toward is a set of validated, standardized quantitative imaging measurements of treatment response that are clinically credible, can be embedded in Phase 1/2 trials, and can be compared across institutions and studies.

What types of organizations are eligible to apply?

Eligibility is described as broad and includes small businesses, for-profit organizations, nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, and additional entities such as certain federal agencies, foreign (non-U.S.) organizations, and regional organizations, as described in the full announcement.

Is cost sharing or matching required?

No. The opportunity does not require cost sharing or matching.

Which CFDA numbers are associated with this funding opportunity?

The opportunity is associated with CFDA numbers 93.394 (Cancer Detection and Diagnosis Research), 93.395 (Cancer Treatment Research), and 93.397 (Cancer Centers Support Grants).

When was this opportunity posted and what are the key dates shown?

The posting date is December 3, 2008. The record reflects later administrative dates, including creation on February 25, 2011. The listing shows an original closing date of September 7, 2011; a current closing date of May 7, 2011; and an archive date of June 7, 2011.

Is this program focused on running cancer treatment trials?

No. The FOA is positioned around imaging endpoints for response assessment. It supports imaging methodology work intended to plug into treatment trials that are already funded or supported, rather than paying for or running the treatment trials themselves.

What kinds of imaging outputs are envisioned as decision tools?

The description emphasizes standardized, reproducible imaging-based measurements (quantitative imaging biomarkers/metrics) that can indicate treatment effects over time and support better, faster decisions in clinical trials, with the longer-term aim of potential use in routine clinical care.

What role does imaging metadata play in this FOA?

Imaging metadata is highlighted as critical for comparability and reproducibility. The network goal includes agreed-upon conventions for recording metadata that affects measurement, such as scanner settings, reconstruction parameters, timing, and contrast use.