Low Cost Tethered Capsule Endoscope with High-Resolution Digital Chromoscopy for Barrett's Screening

用于巴雷特氏筛查的低成本系留胶囊内窥镜，具有高分辨率数字色谱法

• 批准号: 10295900
• 负责人: Sharmila Anandasabapathy
• 金额: $ 65.85万
• 依托单位: RICE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10295900
• 关键词: Adenocarcinoma; Algorithmic Software; Algorithms; Area; Barrett Esophagus; Barrett' s neoplasia; Blood capillaries; Brazil; Cancer Detection; Cancer Etiology; Cessation of life; China; Clinical; Collaborations; Communities; Community Practice; Computer software; Data; Databases; Deglutition; Detection; Development; Devices; Diagnosis; Diagnostic; Disinfection; Dissection; Early Diagnosis; Early treatment; Endoscopes; Endoscopy; Engineering; Esophageal Adenocarcinoma; Esophageal Neoplasms; Esophagus; Evaluation; Family suidae; Feedback; Functional Imaging; Gastrointestinal tract structure; Goals; Gold; High grade dysplasia; Histopathology; Human; IACUC; Image; Image Analysis; Infrastructure; Injections; Injury; Institutional Review Boards; Lateral; Light; Lighting; Malignant Neoplasms; Malignant neoplasm of esophagus; Maps; Modality; Molds; Movement; Mucous Membrane; Neoplasms; Operative Surgical Procedures; Optics; Patients; Performance; Pilot Projects; Process; Provider; Resected; Resolution; Resources; Retrieval; Rice; Rotation; Safety; Sampling; Scanning; Schedule; Screening for cancer; Screening procedure; Sedation procedure; Side; Specimen; Stomach; Support System; Surface; Survival Rate; System; Tablet Computer; Technology; Testing; Time; Tissues; Translations; United States; Visualization; Work; accurate diagnosis; base; capsule; chromoscopy; clinical decision-making; comparative; cost; cost effective; design; digital; ex vivo imaging; experience; high risk population; human study; hypopharynx; imaging approach; imaging capabilities; improved; improved outcome; in vivo evaluation; lens; mortality; multidisciplinary; pill; porcine model; portability; public health relevance; recruit; rural underserved; screening; sensor; standard of care; tool; transmission process; two-dimensional; underserved area

Abstract Esophageal cancer is the 6th leading cause of cancer death worldwide; rates of esophageal adenocarcinoma (EAC) have risen exponentially over the past 4 decades. When EAC is diagnosed at a late stage, 5‐year survival rates are dismal (∼18%). Because of this, increased effort has focused on early detection and treatment of Barrett's esophagus (BE), the only recognized precursor of EAC. Indeed, when esophageal neoplasia is diagnosed at an early stage (Barrett's with high grade dysplasia/intramucosal cancer) and treated endoscopically, 5‐year survival rates exceed 98%. Early detection is currently performed by standard upper endoscopy with high‐definition White Light (WL) and Narrow Band Imaging (NBI) which has been shown to have a sensitivity of >90%. Nonetheless, standard endoscopy is invasive, expensive (commercial scopes >$25,000) AND requires extensive infrastructure for patient exam/sedation. Capsule endoscopy is an appealing alternative option for low‐resource regions (and community practices in the US) that lack infrastructure and expert clinicians. Unfortunately, current commercially available capsule systems lack the spatial‐ resolution to accurately diagnose BE, are single‐use, and are costly (>$25,000 per system, >$350 per single‐use capsule). The goal of this proposal is to develop a lower‐cost , high‐resolution capsule endoscopy system to allow less experienced providers to screen for BE in community‐based settings in the US and low‐resource settings globally. The ScanCap system has two components: a reusable, $75 tethered capsule that is swallowed to collect images of the mucosa and $1000 supporting system to manipulate and display the collected data on a tablet computer. After the capsule is swallowed, the tether is withdrawn and high resolution, NBI images are collected from the entire esophagus. Unlike existing capsule endoscopes, our design enables high resolution side‐viewing of the lumen, with circumferential scanning of the esophagus through guided rotation of the mirror within the capsule as it is withdrawn. The system is portable, battery operated, designed for use by non‐physicians in underserved settings, and can acquire high definition images with NBI to enable visualization of capillary loops. Here, we aim to (1) develop and refine a tethered capsule endoscope (ScanCap) with NBI for esophageal cancer screening, (2) compare the image quality of ScanCap's NBI images to gold‐standard, high‐definition endoscopy with NBI using resected ex vivo samples, (3) evaluate the functional & imaging capabilities and safety of the device in an IACUC‐approved porcine study, and (4) test the imaging performance of ScanCap in a pilot study of 10 patients with documented BE in an IRB‐approved human study. Our multi‐disciplinary team will leverage advances in consumer grade image sensors, injection molded lenses, and optical scanner technology to refine and evaluate a reusable capsule that rivals the performance of high‐definition, state‐of the art NBI endoscopes AND is more cost‐effective (and higher‐resolution) than commercial swallowed capsule systems. The end result will be a lower‐cost, reusable, high quality platform for esophageal cancer screening in community‐based settings in the US and rural, underserved regions worldwide.

摘要 食管癌是世界范围内癌症死亡的第六大原因;食管腺癌（EAC）的发病率 在过去四十年里呈指数级增长。当EAC在晚期被诊断时，5年生存率很低（约18%）。 正因为如此，越来越多的努力集中在早期发现和治疗巴雷特食管（BE），唯一的 公认的EAC前体。事实上，当食管肿瘤在早期被诊断时（Barrett's高分级）， 如果患者接受内镜治疗（非典型增生/粘膜内癌），5年生存率超过98%。早期诊断目前 通过标准上消化道内窥镜进行，采用高清白色光（WL）和窄带成像（NBI）， 其灵敏度可达90%以上。尽管如此，标准内窥镜检查是侵入性的、昂贵的（商业范围 > 25，000美元），并且需要广泛的基础设施进行患者检查/镇静。 胶囊式内窥镜是低资源地区（以及美国的社区实践）的一种有吸引力的替代选择， 缺乏基础设施和专业的临床医生。不幸的是，目前市售的胶囊系统缺乏空间上的灵活性。 准确诊断BE的分辨率是一次性的，并且是昂贵的（每个系统> 25，000美元，每个一次性胶囊> 350美元）。 本提案的目标是开发一种成本更低、分辨率更高的胶囊式内窥镜系统， 提供者在美国的社区环境和全球的低资源环境中筛查BE。ScanCap系统 有两个组成部分：一个可重复使用的，价值75美元的拴系胶囊，可以吞咽下来收集粘膜的图像， 支持系统在平板电脑上操作和显示收集的数据。胶囊被吞下后， 撤回系绳，从整个食管收集高分辨率NBI图像。与现有的胶囊不同 内窥镜，我们的设计能够实现管腔的高分辨率侧视，并对食管进行圆周扫描 通过当其被抽出时镜子在胶囊内的引导旋转。该系统是便携式的，电池供电， 专为非医生在服务不足的环境中使用而设计，并可通过NBI采集高清图像， 毛细血管环的可视化。 在这里，我们的目标是（1）开发和改进用于食管癌筛查的带NBI的栓系胶囊内窥镜（ScanCap）， (2)将ScanCap的NBI图像的图像质量与使用NBI的金标准高清内窥镜进行比较 切除的离体样本，（3）在IACUC批准的 猪研究，以及（4）在10名记录有BE的患者的初步研究中测试ScanCap的成像性能， IRB批准的人体研究。 我们的多学科团队将利用消费级图像传感器、注塑镜头和光学 扫描仪技术，以完善和评估可重复使用的胶囊，竞争对手的性能，高清晰度，国家的 先进的NBI内窥镜AND比市售吞咽胶囊系统更具成本效益（且分辨率更高）。的 最终结果将是一个低成本、可重复使用、高质量的平台，用于社区食管癌筛查。 在美国和世界各地的农村，服务不足的地区。