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 食道癌是全球第六大癌症死亡原因；食管腺癌的发病率 在过去的40年里呈指数级增长。当EAC被诊断为晚期时，5年生存率很低(∼为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道(BE)，这是唯一的 公认的埃博拉病毒前体。事实上，当早期诊断为食道肿瘤时(Barrett‘s高级别 不典型增生/粘膜内癌)和内窥镜治疗，5年存活率超过98%。早期检测目前 由标准上内窥镜和高清晰度白光(WL)和窄带成像(NBI)执行，具有 已被证明具有90%的灵敏度。尽管如此，标准的内窥镜检查是有创的、昂贵的(商业范围 25,000美元)，并且需要为患者检查/镇静提供广泛的基础设施。 胶囊内窥镜检查对于低资源地区(和美国的社区实践)是一个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，目前商业上可用的胶囊系统缺乏空间- 精确诊断BE的解决方案是一次性使用的，而且成本高昂(每个系统25,000美元，每个一次性胶囊350美元)。 这项提议的目标是开发一种低成本、高分辨率的胶囊内窥镜系统，以允许经验较少的人 在美国的社区环境和全球的低资源环境中筛选供应商。ScanCap系统 有两个组成部分：一个可重复使用的75美元的捆绑胶囊，可被吞下以收集粘膜图像，以及1000美元 在平板电脑上操作和显示收集的数据的支持系统。在胶囊被吞下后， 拔下绳索，高分辨率，NBI图像从整个食道收集。与现有胶囊不同 内窥镜，我们的设计能够高分辨率侧视管腔，并对食道进行圆周扫描 当胶囊取出时，通过引导旋转胶囊内的镜子。该系统是便携式的，由电池供电， 专为非医生在服务不足的环境中使用而设计，并可通过NBI获取高清图像以实现 毛细管环的可视化。 在这里，我们的目标是(1)开发和改进一种用于食道癌筛查的带状胶囊内窥镜(ScanCap)， (2)将ScanCap的NBI图像与金标高清内窥镜和NBI的图像质量进行比较 切除体外样本，(3)在IACUC批准的设备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10名有记录的BE患者的试点研究中测试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、注塑透镜和光学领域的先进技术 改进和评估可重复使用胶囊的扫描仪技术，其性能可与高清晰度、状态 ART NBI可用于内窥镜检查，比商用吞咽胶囊系统更具成本效益(且分辨率更高)。这个 最终结果将是一个成本更低、可重复使用、高质量的社区食道癌筛查平台 背景设在美国和世界各地服务不足的农村地区。