SBIR Phase I: Developing a Single-Visit System to Screen, Diagnose, and Treat Cervical Neoplasia

This SBIR Phase I project will develop an innovative 3D medical imaging technology for early-stage detection and analysis of cancers, initially focusing on detecting pre-cancer cervical lesions. This project will advance from creatively assembling existing active optics hardware to inventing a new microfiber-based active optics system to circumvent limits of space confinement and 3D resolution. The project's fundamental strategy for identifying pre-cancers of the cervix, which relies on a macroscopic 3D digital analysis combined with microscopic cell evaluation, is naturally amenable to artificial intelligence technologies. The versatility of this imaging platform enables the resolving of medical diagnostic challenges in wealthy settings and the resolving of cost-saving barriers in resource-limited settings. The imaging technology can be extended beyond medical practice to other scientific and industrial disciplines. Potentially, this project has an immediate impact on saving lives and costs via the early detection of fatal diseases. Additionally, the data and knowledge acquired developing and implementing this imaging system provide opportunities to meaningfully develop new computational strategies for educational, engineering and industrial interests. The innovative, commercially viable, platform technology offers opportunities for significant, tax-revenue-generating global profits, for future technology application spin-offs, and for producing high technology jobs for U.S. citizens. The project innovation will voyage from state-of-the-art 3D software development to the creation of a new type of fiber bundle imager with an electronically controlled actively focusing lens. Combined, these tasks achieve the creation of a miniaturized 3D imaging system capable of navigating confined spaces within the body, such as inside the cervix opening. For all prototypes developed for this project, final 3D renderings are enabled by proprietary 3D rendering software, capable of quantifying tissue color, volume and shape at the macroscopic level, while also evaluating cell size and approximate shape at the microscopic level. In wealthy settings, this system would be desirable for implementing a single-phase cervical cancer screening strategy to replace the current two-phase approach, which requires Pap smear and/or human papilloma virus assay, followed by the more expensive colposcopy in the case of an abnormal result. In resource-limited regions and/or regions with difficult-to-reach populations, where it is challenging to get patients to return for a follow-up visit, the technology would offer a low-cost, pre-screening method that only requires a single visit. This 3D imaging system could be combined in the future with a therapeutic agent administered at the time of diagnosis, thus offering a single-visit, screen-diagnose-and-treat method. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.