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 食道癌是全球癌症死亡的第六个主要原因。食管腺癌（EAC）的发生率 在过去的40年中，成倍增长。当在后期诊断出EAC时，5年的存活率很沮丧（约18％）。 因此，增加的努力集中在对巴雷特食管（BE）的早期检测和治疗上，唯一 公认的EAC前体。确实，当食管肿瘤在早期诊断出（巴雷特高级）时 发育不良/粘膜内癌）和内镜下治疗的5年生存率超过98％。目前正在早期检测 由标准的上内窥镜检查具有高清白光（WL）和窄带成像（NBI）， 被证明具有> 90％的灵敏度。尽管如此，标准内窥镜检查是侵入性的（商业范围） > 25,000美元），需要大量的基础设施来进行患者检查/镇静。 胶囊内窥镜检查是低资源地区（以及美国社区实践）的一种吸引人的替代选择 缺乏基础设施和专业临床医生。不幸的是，当前可商购的胶囊系统缺乏空间 精确诊断的解决方案是一次性的，并且是昂贵的（每个系统> 25,000美元，> 350美元单使用胶囊）。 该提案的目的是开发低成本的高分辨率胶囊内窥镜系统，以减少体验 提供者将在美国和全球低资源设置中筛选为基于社区的设置。 Scancap系统 有两个组件：可重复使用的75美元的束缚胶囊，吞咽以收集粘膜图像和$ 1000 支持系统在平板电脑上操纵和显示收集的数据。胶囊被吞下后， 系绳被撤回并高分辨率，从整个食道收集NBI图像。与现有胶囊不同 内窥镜，我们的设计使腔的高分辨率侧视图，并通过食管周向扫描 通过撤回胶囊内镜子内的镜子的指导旋转。该系统是便携式的，电池操作， 设计旨在在服务不足的设置中使用非物理学家，并可以使用NBI获取高清图像 毛细管环的可视化。 在这里，我们的目标是（1）用NBI开发和完善束缚胶囊内窥镜（scancap）进行食管癌筛查，，， （2）使用使用NBI将Scancap NBI图像的图像质量与金色标准的高清内窥镜检查 切除的离体样品，（3）评估IACUC批准的设备的功能和成像功能和安全性 猪研究和（4）在一项针对10例记录的患者的试点研究中测试Scancap的成像性能 IRB批准的人类研究。 我们的多学科团队将利用消费者级图像传感器，注塑模制镜头和光学的进步 扫描仪技术以完善和评估可重复使用的胶囊，以高清的性能，最先进 与商业吞咽胶囊系统相比，ART NBI内窥镜具有更具成本效益（和更高分辨率）的功能。这 最终结果将是基于社区的食管癌筛查的低成本，可重复使用的高质量平台 在美国以及全球范围内的粗糙，服务不足的地区。