SBIR Phase I: Innovation for an Easy to Use Clinical a/LCI System for in Vivo Detection of Precancer

这个小型企业创新研究(SBIR)第一阶段项目寻求开发新的临床仪器，用于检测大多数癌症的起源--人类上皮组织中的早期癌症。该仪器基于一种新的光学光谱技术，能够在不需要物理切除组织的情况下提供体内细胞核形态的信息。初步实验表明，与组织病理学评估相比，该方法具有非常高的敏感性和特异性。快速准确地检查许多组织部位的能力在临床和研究应用中具有巨大的商业潜力。拟议中的研究将通过简化仪器设计和提供坚固耐用、校准良好的光纤探头来实现临床应用。新的器械设计将通过组织模体实验和活体测量进行验证。这项研究的更广泛影响包括对社会、教育和技术发展的好处。拟议的光学系统将使社会受益，因为它有可能通过提供组织健康的即时反馈，同时避免随机活检，极大地改善内窥镜筛查和监测上皮组织的癌症迹象。我们将通过会议演示和针对研究市场的硬件产品，使这项技术能够在教学、研究和工业中使用。最后，拟议的技术产品具有非常高的商业化潜力，因此成功的开发将导致雇用电气和生物医学工程师等技术人员。

This Small Business Innovation Research (SBIR) Phase I project seeks to develop new clinical instrument for detecting early stage cancer in human epithelial tissues, the origin of most cancers. The instrument is based on a novel optical spectroscopic technology which is capable of providing information about cell nuclear morphology in vivo without the need to physically remove tissue. Preliminary experiments have shown a very high level of sensitivity and specificity when compared to pathological evaluation of tissue. The ability to quickly and accurately examine many tissue sites translates to significant commercial potential in clinical and research applications. The proposed research will enable clinical usage by simplifying instrument design and providing a robust, well calibrated fiber probe. The new instrumentation design will be validated with tissue phantoms experiments and in vivo measurements.The broader impacts of this research include benefits to society, education and technology development. The proposed optical system will benefit society as it has the potential to greatly improve endoscopic screening and surveillance of epithelial tissues for signs of cancer by providing instant feedback on tissue health while avoiding the need for random biopsy. We will enable utilization of this technology in teaching, research, and industry through conference presentations and hardware offerings aimed at the research market. Finally, the proposed technology products has a very high commercialization potential such that successful development will lead to employment of technical staff such as electrical and biomedical engineers.