SBIR Phase I: Large Area Scanning Angle-resolved Low Coherence Interferometry (a/LCI) for Endoscopic Precancer Detection

这个小型企业创新研究（SBIR）第一阶段项目旨在开发一种新的临床仪器，能够使用新的光学技术扫描大面积的上皮组织，以检测和定位癌前病变。 光学技术，角度分辨低相干干涉术（a/LCI）在Barrett食管患者的体内测试期间显示出检测癌前病变的出色灵敏度和特异性，但仅限于单点测量。为了获得最大的临床效果，必须将该模式扩展到扫描广泛的组织区域。由于a/LCI方法的独特成像几何结构，该项目将提供显著的优势。虽然已经研究了用于传统成像方法的扫描方案的使用，但是a/LCI方法依赖于测量散射光的角分布。因此，a/LCI的广域扫描实现将需要新颖的光学设计来解决成像中通常不感兴趣的问题。该研究计划要求建立一个扫描系统，能够在一秒钟内询问至少5个相隔1毫米的位置，而无需重新定位探头，以证明该方法的概念验证。该项目的更广泛的影响/商业潜力集中在早期癌症检测和诊断领域。上皮组织健康的传统评估需要系统的组织切除，随后由病理学家进行检查。活检取样误差是早期癌组织经常逃避检测的一个重要问题，因为在组织表面可能没有疾病的证据。所提出的a/LCI系统具有极大地改善上皮组织的癌前病变的内窥镜筛查和监测的潜力。 与执业临床医生的访谈和a/LCI技术初始现场试验现场的反馈表明，该仪器已被广泛市场采用，但也确定了自动组织扫描优于当前点成像模式的偏好。所提出的广域扫描系统的高通量将以一种不可能使用切除活检的组织病理学评价的方式提供组织健康的全面评估。a/LCI系统的低成本及其易用性将使其广泛应用成为可能，这是当前医疗保健环境中日益重视的一个因素。

This Small Business Innovation Research (SBIR) Phase I project seeks to develop a new clinical instrument capable of using a novel optical technology to scan large areas of epithelial tissue for the detection and localization of precancers. The optical technology, angle-resolved Low Coherence Interferometry (a/LCI) has shown excellent sensitivity and specificity for detecting precancerous lesions during in vivo testing with Barrett's Esophagus patients but has been confined to single point measurements. To have the greatest clinical impact, the modality must be extended to scan wide tissue areas. This project will offer significant advantages due to the unique imaging geometry of the a/LCI approach. While the use of scanning schemes for traditional imaging methods have been investigated, the a/LCI approach relies on measuring the angular distribution of scattered light. Thus, wide area scanning implementations of a/LCI will require a novel optical design to address issues not commonly of interest in imaging. The research plan calls for building a scanning system capable of interrogating at least 5 locations separated by 1 millimeter within one second without repositioning the probe to demonstrate proof-of-concept for the approach.The broader impact/commercial potential of this project centers on the field of early cancer detection and diagnosis. Traditional evaluation of the health of epithelial tissues requires systematic tissue removal with subsequent examination by a pathologist. Biopsy sampling error is a significant problem with early cancerous tissues often eluding detection, as there may not be evidence of disease at the tissue surface. The proposed a/LCI system has the potential to greatly improve endoscopic screening and surveillance of epithelial tissues for precancerous lesions. Interviews with practicing clinicians and feedback from initial field trial sites of the a/LCI technology point to widespread market adoption of this instrument but also identify the preference for automated tissue scanning over the current point imaging modality. The high throughput of the proposed wide area scanning system will provide comprehensive assessments of tissue health in a way that is not possible using histopathological evaluation of excised biopsies. The low cost of the a/LCI system and its ease-of-use will enable widespread applications, a factor which is increasingly valued in the current, fiscally conscious health care environment.