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: 10672889
• 负责人: Sharmila Anandasabapathy
• 金额: $ 62.64万
• 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/10672889
• 关键词: Adenocarcinoma; Algorithms; 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; Disinfection; Dissection; Early Diagnosis; Early treatment; Electronics; Endoscopes; Endoscopy; Engineering; Esophageal Adenocarcinoma; Esophageal Neoplasms; Esophagogastric Junction; Esophagus; Evaluation; Family suidae; Feedback; Gastrointestinal tract structure; Goals; 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; Resource-limited setting; Retrieval; Rice; Rotation; Rural; Safety; Sampling; Scanning; Schedule; Screening for cancer; Screening procedure; Sedation procedure; Side; Specimen; Stomach; Submucosa; Support System; Surface; Survival Rate; System; Tablet Computer; Technology; Testing; Time; Tissues; Translations; United States; Visualization; Work; accurate diagnosis; capsule; chromoscopy; clinical decision-making; comparative; cost; cost effective; design; diagnostic criteria; 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; 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.

抽象的 食管癌是全球第六大癌症死亡原因；食管腺癌 (EAC) 的发病率 过去 4 年来呈指数级增长。当 EAC 在晚期诊断时，5 年生存率很低（约 18%）。 因此，越来越多的努力集中在巴雷特食管 (BE) 的早期检测和治疗上，这是唯一的治疗方法。 公认的 EAC 前身。事实上，当食管肿瘤在早期被诊断出来时（巴雷特氏病具有高级别） 不典型增生/粘膜内癌）并通过内镜治疗，5年生存率超过98%。目前早期检测 通过具有高清白光 (WL) 和窄带成像 (NBI) 的标准上消化道内窥镜检查进行， 已证明其灵敏度 >90%。尽管如此，标准内窥镜检查是侵入性的、昂贵的（商业内窥镜） > 25,000 美元）并且需要大量基础设施用于患者检查/镇静。 对于资源匮乏地区（以及美国的社区实践）来说，胶囊内窥镜检查是一种有吸引力的替代选择 缺乏基础设施和专业临床医生。不幸的是，当前市售的胶囊系统缺乏空间- 准确诊断 BE 的分辨率，是一次性的，而且价格昂贵（每个系统 > 25,000 美元，每个一次性胶囊 > 350 美元）。 该提案的目标是开发一种成本较低、高分辨率的胶囊内窥镜系统，以方便经验较少的人 提供商在美国的社区环境和全球资源匮乏的环境中筛查 BE。 ScanCap系统 有两个组件：一个可重复使用、价值 75 美元的系留胶囊，吞下后可收集粘膜图像；另一个价值 1000 美元 支持系统在平板电脑上操作和显示收集的数据。吞服胶囊后， 撤回系绳并从整个食道收集高分辨率 NBI 图像。与现有胶囊不同 内窥镜，我们的设计可实现管腔的高分辨率侧视，并对食道进行圆周扫描 当镜子被抽出时，通过引导镜子在胶囊内旋转。该系统是便携式的、电池供电的、 设计供非医生在服务不足的环境中使用，并且可以通过 NBI 获取高清图像，以实现 毛细血管环的可视化。 在这里，我们的目标是 (1) 开发和完善带有 NBI 的系留胶囊内窥镜 (ScanCap)，用于食道癌筛查， (2) 使用 NBI 将 ScanCap 的 NBI 图像与金标准、高清内窥镜检查的图像质量进行比较 切除的离体样本，(3) 在 IACUC 批准的环境中评估设备的功能和成像能力以及安全性 猪研究，以及 (4) 在一项试点研究中测试 ScanCap 的成像性能，该研究对 10 名记录有 BE 的患者进行了试验 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、注塑镜头和光学方面的进步 扫描仪技术来改进和评估可重复使用的胶囊，其性能可与高清、最新状态的胶囊相媲美 art NBI 内窥镜比商业吞咽胶囊系统更具成本效益（且分辨率更高）。这 最终结果将是一个低成本、可重复使用的高质量平台，用于社区食管癌筛查 美国和世界各地农村、服务欠缺地区的环境。