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，最初的重点是检测癌前宫颈病变。该项目将从创造性地组装现有的主动光学硬件推进到发明一种新的基于微光纤的主动光学系统，以绕过空间限制和3D分辨率的限制。该项目用于识别宫颈癌前期的基本策略依赖于宏观3D数字分析与微观细胞评估相结合，自然适合人工智能技术。该成像平台的多功能性能够解决富裕环境中的医疗诊断挑战，并解决资源有限环境中的成本节约障碍。该成像技术可以从医疗实践扩展到其他科学和工业学科。通过早期发现致命疾病，该项目可能对挽救生命和降低成本产生直接影响。此外，开发和实施该成像系统所获得的数据和知识为教育、工程和工业利益提供了有意义的开发新计算策略的机会。这种创新的、商业上可行的平台技术为产生重大的全球利润、未来的技术应用衍生产品以及为美国公民创造高科技就业机会提供了机会。该项目的创新将从最先进的3D软件开发到创建一种新型的光纤束成像仪，该成像仪带有电子控制的主动聚焦透镜。这些任务结合在一起，实现了一个小型化的3D成像系统的创建，该系统能够导航体内的受限空间，例如宫颈开口内。对于本项目开发的所有原型，最终的3D渲染是通过专有的3D渲染软件实现的，能够在宏观水平上量化组织的颜色、体积和形状，同时也可以在微观水平上评估细胞的大小和近似形状。在富裕的环境中，该系统将适用于实施单相宫颈癌筛查策略，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，然后在结果异常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，很难让患者返回进行随访，该技术将提供一种低成本的预筛查方法，只需要一次访问。这种3D成像系统将来可以与诊断时使用的治疗剂相结合，从而提供单次就诊、筛查诊断和治疗的方法。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.