Improving colonoscopic miss rate by real time microvascular blood analysis

通过实时微血管血液分析提高结肠镜检查漏检率

• 批准号: 7683890
• 负责人: Hemant K. Roy
• 金额: $ 34.63万
• 依托单位: AMERICAN BIOOPTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-28 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7683890
• 关键词: Aberrant crypt foci; Adenomatous Polyps; Adjuvant; Age Factors; Algorithms; American; Animals; Area; Azoxymethane; Biomedical Engineering; Biophotonics; Biopsy; Blood; Blood Circulation; Body mass index; Businesses; Cancer Etiology; Carcinoma; Cardiopulmonary; Cardiovascular system; Cecum; Cessation of life; Clinical; Clinical Engineering; Clinical Medicine; Clinical Research; Colitis; Colon; Colon Carcinoma; Colonic Adenoma; Colonic Neoplasms; Colonoscopes; Colonoscopy; Colorectal Cancer; Community Practice; Computer software; Computers; Data; Defensive Medicine; Demographic Factors; Detection; Development; Diagnostic; Discrimination; Dysplasia; Endoscopes; Endoscopy; Epithelial; Epithelium; Excision; Feces; Fiber Optics; Figs - dietary; Fingerprint; Four-dimensional; Gastroenterologist; Gastroenterology; Gender; Generations; Genus Cola; Goals; Gold; Group Practice; Guidelines; Hand; Healthcare; Hemoglobin; Histologic; Human; Image; Internal Medicine; Legal; Lesion; Licensing; Litigation; Localized Lesion; Logistic Regressions; Maintenance; Malignant Neoplasms; Maps; Marketing; Measures; Medical; Medicine; Mucous Membrane; Nature; Neoplasms; Newly Diagnosed; Optics; Patients; Performance; Phase; Physicians; Pilot Projects; Polypectomy; Polyps; Preparation; Procedures; Quality Control; Race; Randomized; Reading; Regression Analysis; Reporting; Residual state; Resources; Retinal blind spot; Risk; Sensitivity and Specificity; Side; Source; Specificity; Speed; Staging; Surface; System; Techniques; Technology; Technology Transfer; Testing; Time; Tissues; Tobacco; Ulcerative Colitis; United States; Universities; Vascular blood supply; Visual; Withdrawal; acronyms; adenoma; base; cancer prevention; carcinogenesis; clinical application; clinical practice; colon carcinogenesis; colon hepatic flexure; colorectal cancer prevention; commercialization; data acquisition; deoxyhemoglobin; depressed; digital; experience; improved; in vivo; instrumentation; interest; light scattering; member; multidisciplinary; neoplastic; novel; pressure; prevent; product development; prospective; tumor

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.

项目摘要/描述 这个小型企业技术转移申请的目标是验证和 在结肠镜检查过程中商业化改进的息肉检测方法：光谱学 内镜下正常粘膜的微血管血液评估。错过病变 关于结肠镜检查是一个主要问题（保守估计约占腺瘤的25％ 和约4-5％的癌症）具有毁灭性的临床和法律后果。 尽管正在开发各种辅助方法，但这些方法缺乏灵敏度或 临床医学的实用性。我们的突破性技术四维弹性 散落的指纹识别（4D-ELF）允许下皮的前所未有的准确性 微举行分析。使用这种方法，我们首次报告了 在组织学正常粘膜中，血液供应（EIBS）早期增加 实验性动物冒着结肠肿瘤的风险。因此，EIBS似乎很早就 “田间致癌”的标记。这在人类结肠镜研究中得到了证实 使用组织活检和光纤4D-ELF探针（约400名患者）。重要的是， 仅在结肠段才能检测到微血管血液含量增加 （结肠的〜1/3），该病变具有损害，大小反映了与 息肉。基于此初步数据，我们假设实时EIBS评估 将提高结肠镜检查过程中肿瘤检测的准确性。在第1阶段 STTR，我们建议确定微血管血液含量的阈值（截止）水平 （总和脱氧血红蛋白）用于歧视肿瘤的结肠段 考虑各种潜在的EIB修改因素（年龄，性别等）。一个里程碑 过渡到项目的第2阶段将是发展高度准确的 预测规则。第2阶段将包括一项随机研究，以评估真实的影响 时间EIBS有关1600名患者腺瘤检测率的信息。腺瘤检测 将比较有或没有EIB的速率。我们的保守估计是EIBS 指导将使息肉的失误率至少提高50％。我们相信EIBS涉及 将允许内镜医生快速确定是否有结肠段 肿瘤。如果EIB为负，则可以快速视觉检查。此外，它 将有助于相对常见的情况，例如无法到达盲肠或粘膜 残留粪便晦涩。另一方面，读数暗示了一个息肉不是 易于可视化，然后映射EIBS幅度可以提供精确的 本土化。鉴于这种技术成熟方法的临床承诺，我们 设想这可以通过直接通过美国生物t的商业化。 基于探针的系统的制造/分发。或者，EIBS检测可以 通过内窥镜直接将其直接纳入结肠镜 公司。