Description:
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will NOT be accepted
Number of anticipated awards: 2-3 Budget (total costs, per award):
Phase I: up to $400,000 for up to 9 months Phase II: up to $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
Quantitative imaging software tools developed in academic settings are typically developed for specific research purposes and are often validated only within the home institution. However, for such software 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 goal of this solicitation is to support commercial development by small businesses of new, or existing quantitative imaging (QI) software tools with utility to radiologists who rely on patient medical images for accurate cancer diagnosis and radiation treatment planning. QI tools can be developed de novo for commercial purposes under this solicitation. Alternatively, existing tools can be advanced toward commercialization, and candidates include several well developed tools produced by the NCI Quantitative Imaging Network (QIN; see https://imaging.cancer.gov/programs_resources/specialized_initiatives/qin/tools/default.htm) for the purpose of quantifying or predicting response to cancer therapy in human clinical trials. Within QIN, teams of academic researchers have been developing and optimizing tools of various functions for eventual deployment into clinical trials. Possible paths for commercialization of existing QIN tools include small business partnership (with a QIN team or other academic institution) to take the lead in translating an academic QI tool into clinical validation, or for the academic institution to form a new small business for the purpose of QI tool commercialization.
Project Goals
Commercialization by small businesses is expected to produce robust, well documented and well supported software tools after iterative optimization and validation through quality management controls. Furthermore, the software tool will function on several hardware vendor platforms for the common cancer medical imaging modalities (CT, MRI, ultrasound, PET).
Under this solicitation, NCI will not support development of software usable on only one vendor platform. The QI tools are intended to have improved cancer detection capabilities, diagnostic accuracy, and utility for radiation treatment planning and cancer treatment decisions to provide the potential for widespread impact on the clinical community.
The small business offeror will be required to specify a cancer imaging use case (e.g. an imaging modality, a specific cancer type, and cancer diagnosis versus monitoring versus radiation treatment planning) to focus on, and will need to clearly describe deidentified medical image data sets and their source for the purposes of conducting the proposed research.
Quantitative milestones - with performance targets that define success – should be provided for each project objective.
Phase I Activities and Deliverables:
• Convene the project team with expertise in medical image software design, informatics, radiology, and medical oncology or radiation oncology to review and finalize the software design
• Build Alpha software prototype
• Evaluate Alpha software performance via retrospective analysis of deidentified medical image data sets
• Refine software as needed, and repeat software evaluation via retrospective analysis of deidentified medical image data sets
• Perform small-scale Usability testing, requiring a minimum of 10 end users at 5 different sites
• Develop plans for a pre-regulatory submission dialogue with the FDA, to be completed before submission of a SBIR Phase II proposal, so that FDA requirements can be included in the SBIR Phase II research plan
Phase II Activities and Deliverables:
• Refine, and build the Beta version of the software based on Phase I results
• Perform large-scale Usability testing, requiring a minimum of 30 end users at 15 sites
• Refine software as needed
• Evaluate software performance via retrospective analysis of deidentified, retrospective medical image data sets
• Evaluate software performance with statistical significance via analysis of newly collected medical images in an IRB-approved, prospective clinical trial
• File regulatory submission with FDA by the end of year-02, following either the 510k or PMA path (as required by FDA for the specific product use and claims sought by the contractor)
• Secure two letters of commercial interest from potential customers at the end of year-01
• Secure two letters of commercial commitment to buy the product from customers at the end of year-02
