High Resolution Microendoscopy for the Management of Esophageal Neoplasia

高分辨率显微内窥镜治疗食管肿瘤

基本信息

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
项目类别：
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

项目摘要

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）：尽管化学放疗疗法进展，但由于在晚期，无法治愈的阶段诊断，食管鳞状细胞肿瘤（ESCN）的五年生存率仍然是15％。内窥镜筛查通常在高风险种群中进行粘膜的碘染色和异常（未染色）区域的靶向活检。虽然卢格（Lugol）显着提高了白光内窥镜检查的敏感性（> 95％），但特异性仍然很差（<65％），因为炎症和其他良性粘膜变化模仿肿瘤。虽然已证明共聚焦微型镜检查可显着提高卢格尔色彩内窥镜检查的诊断准确性和产量，但现有平台的昂贵（> 150,000美元），并且仅在全球少数三级中心提供。我们的小组开发了一种便携式，电池操作的高分辨率微型镜（MHRME），可提供食管上皮的亚细胞图像，描述与肿瘤有关的细胞和形态变化。在最近的一项单臂试验试验（R21）中，HRME显着提高了Lugol筛查的敏感性和特异性，达到100％和89％。基于我们广泛的初步数据，我们现在建议使用软件界面优化和验证基于平板电脑的低成本（<$ 1600）的系统，该系统提供了实时图像解释辅助，从而促进了低层资源环境中经验不足的临床医生的使用。我们的中心假设是，这种“光学”方法将提高当前内窥镜筛查和监视标准的效率，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，将其与当前美国和中国的内窥镜筛查/监视标准进行比较。此外，我们将构建，完善和分析ESC的疾病模型，以确定将HRME纳入两国内窥镜筛查和监视的有效性和成本效益。成功的结果可以轻松地转化为其他器官（子宫颈，结肠等）中的全球癌症筛查。