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

这个SBIR一期项目将开发一种创新的3D医学成像技术，用于癌症的早期检测和分析，最初专注于检测癌前病变。该项目将从创造性地组装现有的有源光学硬件发展到发明一种新的基于微光纤的有源光学系统，以绕过空间限制和3D分辨率的限制。该项目识别宫颈癌前病变的基本战略依赖于宏观3D数字分析和微观细胞评估，自然受制于人工智能技术。该成像平台的多功能性使其能够在富裕的环境中解决医疗诊断挑战，并在资源有限的环境中解决成本节约障碍。成像技术可以从医疗实践扩展到其他科学和工业学科。该项目可能会通过及早发现致命疾病对拯救生命和成本产生立竿见影的影响。此外，开发和实施这一成像系统所获得的数据和知识为有意义地为教育、工程和工业利益开发新的计算策略提供了机会。这种创新的、商业上可行的平台技术为全球创造了可观的税收收入，为未来的技术应用衍生产品提供了机会，并为美国公民创造了高科技工作机会。该项目的创新将从最先进的3D软件开发过渡到创造一种新型的光纤束成像仪，该成像仪具有电子控制的主动聚焦镜头。这些任务结合在一起，实现了一种微型3D成像系统的创建，该系统能够在身体内的受限空间导航，例如在宫颈开口内。对于为该项目开发的所有原型，最终的3D渲染由专有的3D渲染软件实现，能够在宏观水平上量化组织的颜色、体积和形状，同时在微观水平上评估细胞大小和近似形状。在富裕的环境中，这一系统对于实施单期宫颈癌筛查策略是可取的，以取代目前的两阶段方法，即需要巴氏涂片和/或人乳头瘤病毒检测，然后在出现异常结果的情况下进行更昂贵的阴道镜检查。在资源有限的地区和/或人口难以到达的地区，让患者返回进行后续访问具有挑战性，该技术将提供一种只需一次访问的低成本预筛查方法。这种3D成像系统未来可以与诊断时使用的治疗剂相结合，从而提供一种单次访问、筛查诊断和治疗的方法。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.