Improving colonoscopic miss rate by real time microvascular blood analysis

项目概要/描述 这个小型企业技术转让应用程序的目标是验证和 将结肠镜检查期间息肉检测的改进方法商业化：光谱 从内窥镜检查正常粘膜的微血管血液评估。遗漏病变 结肠镜检查是一个主要问题（保守估计约25%的腺瘤 约4-5%的癌），具有毁灭性的临床和医学法律后果。 虽然正在开发各种佐剂方法，但这些方法缺乏敏感性或毒性。 临床医学的实用性。我们的突破性技术四维弹性 光散射指纹（4D-ELF）允许前所未有的准确性， 微血管分析。使用这种方法，我们首次报告， 在组织学正常的粘膜中， 有结肠肿瘤风险的实验动物。因此，EIBS似乎是一个早期的 “现场致癌作用”的标志物。这在人类结肠镜检查研究中得到证实 使用组织活检和光纤4D-ELF探头（约400例患者）。重要的是， 增加的微血管血液含量仅在结肠段中可检测到 （约1/3的结肠），其大小反映了病变的接近程度。 息肉基于这些初步数据，我们假设实时EIBS评估 将提高结肠镜检查中肿瘤检测的准确性。在第一阶段， STTR，我们建议确定微血管血液含量的阈值（截止）水平 （总血红蛋白和脱氧血红蛋白）用于鉴别含有瘤形成的结肠节段 考虑各种潜在的EIBS修改因素（年龄、性别等）。里程碑， 过渡到第二阶段的项目将是一个高度准确的发展， 预测规则第2阶段将包括一项随机研究，以评估真实的 时间EIBS信息对1600例腺瘤检出率的影响。腺瘤检出 将比较有和没有EIBS的比率。我们的保守估计是， 引导将使息肉漏诊率至少提高50%。我们认为， 将允许内窥镜医师快速确定结肠段是否具有 肿瘤形成如果EIBS为阴性，则可以进行快速目视检查。而且 将有助于相对常见的情况，如无法到达盲肠或粘膜 残留粪便使其模糊。另一方面，如果读数显示息肉不是 容易可视化，然后映射EIBS幅度可以提供精确的 本地化鉴于这种技术成熟的方法的临床前景，我们 设想这可以很容易地由美国生物光学公司通过直接 基于探针的系统的制造/分销。或者，EIBS检测可以 通过与内窥镜的伙伴关系直接并入结肠镜 公司

Project Summary/Description The goal of this small business technology transfer application is to validate and commercialize an improved means of polyp detection during colonoscopy: spectroscopic microvascular blood assessment from the endoscopically normal mucosa. Missed lesions on colonoscopy are a major problem (conservatively estimated to be ~25% of adenomas and ~4-5% of carcinomas) with devastating clinical and medico-legal consequences. While various adjuvant approaches are being developed, these lack either sensitivity or practicality for clinical medicine. Our breakthrough technology four dimensional elastic light-scattering fingerprinting (4D-ELF) allows unprecedented accuracy in sub-epithelial microvasculature analysis. Using this approach, we have reported, for the first time, that there is an early increase in blood supply (EIBS) in the histologically normal mucosa in experimental animals at risk for colon neoplasia. Thus, EIBS appeared to be an early marker of the "field carcinogenesis". This was confirmed in human colonoscopic studies using both tissue biopsies and a fiberoptic 4D-ELF probe (~400 patients). Importantly, the increased microvascular blood content was only detectable in the colonic segment (~1/3 of colon) that harbored the lesion and the magnitude mirrored the proximity to the polyp. Based on this preliminary data we hypothesize that real-time EIBS assessment will improve accuracy of neoplasia detection during colonoscopy. In phase 1 of the STTR, we propose to determine threshold (cut-off) levels of microvascular blood content (total and deoxyhemoglobin) for discrimination of colonic segments that harbor neoplasia factoring various potential EIBS modifying factors (age, gender, etc). The milestone for transition into phase 2 of the project will be the development of a highly accurate prediction rule. Phase 2 will consist of a randomized study to assess the impact of real time EIBS information on adenoma detection rate in 1600 patients. Adenoma detection rate with and without EIBS will be compared. Our conservative estimate is that EIBS guidance will improve polyp miss rate by at least a 50%. We believe that EIBS-guidance will allow the endoscopist to rapidly determine whether a colonic segment harbors neoplasia. If EIBS is negative, then rapid visual inspection is possible. Furthermore, it would aid in the relatively common scenarios such as inability to reach cecum or mucosal obscuration by residual stool. If, on the other hand, readings suggest a polyp that is not readily visualizable, then mapping the EIBS magnitude could provide precise localization. Given the clinical promise of this technologically-mature approach, we envision that this can be readily commercialized by American BioOptics through direct manufacturing/distribution of a probe-based system. Alternatively, EIBS detection could be incorporated directly into the colonoscope via parternship with an endoscope company.