High Resolution Microendoscopy for the Management of Esophageal Neoplasia

高分辨率显微内窥镜治疗食管肿瘤

• 批准号: 9325455
• 负责人: Sharmila Anandasabapathy
• 金额: $ 108.86万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-17 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9325455
• 关键词: Africa; Area; Benign; Biopsy; Cellular Morphology; Cervix Uteri; Characteristics; China; Chinese People; Clinical; Colon; Communities; Computer software; Contrast Media; Country; Data; Devices; Diagnosis; Disease; Disease model; Early Diagnosis; Early identification; Effectiveness; Eligibility Determination; Endoscopy; Environment; Epithelial; Epithelium; Esophageal; Esophageal Squamous Cell; Evaluation; Geographic Locations; Goals; Health system; Hour; Image; Image Analysis; Incidence; Inflammation; Intuition; Iodine; Iran; Light; Malignant Neoplasms; Malignant neoplasm of esophagus; Methods; Modeling; Morbidity - disease rate; Mucous Membrane; Multicenter Trials; Neoplasms; Nuclear; Operative Surgical Procedures; Optical Biopsy; Optics; Organ; Pathology; Patients; Performance; Pleomorphism; Procedures; Randomized; Randomized Clinical Trials; Research Infrastructure; Resolution; Resources; Risk; Safety; Screening for cancer; Sensitivity and Specificity; Specificity; Staining method; Stains; Stomach; Survival Rate; System; Tablets; Techniques; Time; Tissues; Translating; United States; arm; base; chemoradiation; chromoscopy; cost; cost effective; cost effectiveness; data acquisition; diagnostic accuracy; experience; follow-up; global health; high resolution imaging; high risk population; image guided; imaging software; improved; in vivo; microendoscope; microendoscopy; mortality; novel; outcome forecast; pilot trial; portability; programs; prospective; prototype; public health relevance; randomized trial; screening; standard of care; success; trial comparing

DESCRIPTION (provided by applicant): Despite advances in chemoradiation therapy, the five-year survival rate for esophageal squamous cell neoplasia (ESCN) remains a dismal 15% due to diagnosis at a late, incurable stage. Endoscopic screening is typically performed in high-risk populations with Lugol's iodine staining of the mucosa and targeted biopsy of abnormal (unstained) areas. While Lugol's significantly increases the sensitivity of white light endoscopy (>95%), specificity remains poor (<65%) as inflammation and other benign mucosal changes mimic neoplasia. While confocal microendoscopy has been shown to dramatically enhance the diagnostic accuracy and yield of Lugol's chromoendoscopy, existing platforms are costly (>$150,000) and only available in a handful of tertiary centers worldwide. Our group has developed a portable, battery-operated, high-resolution microendoscope (mHRME) that provides subcellular images of the esophageal epithelium, delineating the cellular and morphologic changes associated with neoplasia. In a recent, single-arm pilot trial (R21), the HRME significantly increased the sensitivity and specificity of Lugol's screening to 100% and 89%. Based on our extensive preliminary data, we now propose to optimize and validate a lower-cost (<$1600), tablet-based system with a software interface that provides real- time image interpretation assistance, thus facilitating usage by less-experienced clinicians in low-resource settings. Our central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of endoscopic screening and surveillance. To validate this, we will conduct a randomized, multicenter trial of our 'optical biopsy' approach comparing it to the current standard of endoscopic screening/surveillance in the U.S. and China. In addition, we will construct, refine and analyze a disease model of ESCN to determine the effectiveness and cost-effectiveness of incorporating HRME into endoscopic screening and surveillance in both countries. Successful results can easily be translated to global cancer screening in other organs (cervix, colon, etc.).

描述（由申请人提供）：尽管放化疗取得了进展，但食管鳞状细胞瘤（ESCN）的5年生存率仍然是令人沮丧的15%，因为诊断晚期，无法治愈。内镜筛查通常在高危人群中进行，对粘膜进行Lugol's碘染色，并对异常（未染色）区域进行靶向活检。虽然Lugol's明显增加了白光内镜的敏感性（bb0 95%），但特异性仍然很差（<65%），因为炎症和其他良性粘膜改变类似于肿瘤。虽然共聚焦显微内窥镜已被证明可以显著提高Lugol色内窥镜的诊断准确性和产量，但现有的平台价格昂贵（150万美元），并且仅在全球少数三级中心可用。我们的团队开发了一种便携式、电池供电、高分辨率的显微内窥镜（mHRME），可提供食管上皮的亚细胞图像，描绘与肿瘤相关的细胞和形态学变化。在最近的一项单臂先导试验（R21）中，HRME显著提高了Lugol筛查的敏感性和特异性，分别达到100%和89%。基于我们广泛的初步数据，我们现在建议优化和验证一种低成本（< 1600美元）、基于平板电脑的系统，该系统具有软件界面，可提供实时图像解释辅助，从而促进经验不足的临床医生在低资源环境下的使用。我们的中心假设是，这种“光学”方法将提高目前内镜筛查和监测标准的效率、临床影响和成本效益。为了验证这一点，我们将对我们的“光学活检”方法进行随机、多中心试验，将其与美国和中国目前的内窥镜筛查/监测标准进行比较。此外，我们将构建、完善和分析ESCN疾病模型，以确定将HRME纳入两国内窥镜筛查和监测的有效性和成本效益。成功的结果可以很容易地转化为其他器官（子宫颈癌、结肠癌等）的全球癌症筛查。