Key Dates

Related Announcements

PAR-20-155 - Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems (R01 Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

Purpose

This NOSI highlights the NCI Cancer Imaging Program's interest in receiving investigator-initiated grant applications focused on the translation of mature well-developed and optimized quantitative imaging (QI) tools and methods for prediction and/or measurement of response to cancer therapies, or for planning and translating radiation therapy treatment strategies in clinical trials and workflow.

Background and Research Objectives

The goal of quantitative imaging is to create the condition where clinical imaging devices behave as measurement instruments, providing clinicians with reliable and reproducible numeric (i.e. quantitative) information to predict or measure the health status of patients, or to plan treatment strategies. QI tools developed in academic settings are typically developed for specific research purposes and are often validated only within the home institution. However, for such tools to become widely useful in the clinical oncology community, the tools require rigorous validation at multiple sites, and with dynamic interplay between the tool developer and the clinician end users (radiologists, oncologists) to further refine, optimize, and validate the tool.

The overall goal of this NOSI is to translate well-developed QI tools for potential utility to oncologists and radiologists who rely on cancer in vivo images for accurate diagnosis and treatment planning. Active collaborations between academia and industrial partnerships are expected to result in robust quality management controls, with continual interplay between the AIP QI team and clinicians, which will lead to the production of high-quality QI tools through several rounds of iterative optimizations and validation. Therefore, this NOSI for AIP is an ideal platform to initiate translation of well-developed QI tools for dissemination and integration into clinical oncology community workflow.

The research goals of this NOSI include:

1. Translation of well-developed QI tools for treatment planning, predicting or measuring response to therapy as tools which can translate into clinical trial decision support;
2. Validation of the optimized tools in clinical settings to demonstrate their value for decision support in ongoing multi-site clinical trials.

NCI encourages AIP to validate well-developed mature quantitative tools with potential for widespread impact on the clinical community with new or improved cancer detection capabilities, diagnostic accuracy, and utility for cancer treatment decisions.

The activities that fall within the scope of this NOSI include:

(i) validation and integration of well-developed Quantitative Imaging tools into the clinical workflow.

(ii) the ultimate aim towards gaining FDA approval for tool commercialization. The academic investigators will actively collaborate with a industrial partner who will help refine a specific quantitative imaging tool chosen for its potential clinical utility with the goal of a well formulated plan as demonstrated by appropriately chosen objective performance targets.

The AIP team is expected to validate the developed and optimized QI tool and to provide:

(i) their clinical teams with end-user customer support infrastructure and quality assurance (QA) management;

(ii) development and optimization of appropriate user support for the tool;

(iii) coordination with necessary regulatory agencies such as the institutional IRBs for approvals to integrate mature quantitative imaging tools into existing or planned clinical trials across multiple sites; and

(iv) an ultimate aim to initiate pursuit of FDA premarket equivalency (510k) or premarketing approval (PMA).

Activities and Deliverables

• Academic investigators will collaborate with industrial partner(s) and execute a detailed plan for translating well-developed quantitative imaging tool(s) through a series of steps which will demonstrate potential for clinical utility through retrospective and/or prospective studies as appropriate:
  1. The AIP team members will launch on their strategic objectives to ready a pre-commercial version for prospective clinical validation.
  2. The AIP team members will acquire institutional IRB approval(s) as needed for prospective validation of chosen tool(s) in existing or planned clinical trial(s) without influencing clinical trial outcomes.
• The industrial partner will help develop and implement QA management plans through customer support for the chosen QI tool(s) deployed in clinical settings
• The industrial partner will help develop and implement plans for optimizing a user interface protocol for the selected QI software tool(s).
• The AIP team will engage with the FDA for developing a regulatory strategy and timeline for an IDE submission for the selected tool(s) which could potentially lead to the selected clinically validated tool for commercialization.

Application and Submission Information

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-CA-21-032” (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 R&R form. Applications without this information in Box 4b will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Robert J. Nordstrom, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5934
Email: nordstrr@mail.nih.gov

Darrell Tata, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5894
Email: Darrell.Tata@nih.gov