Automated, Augmented Reality High Resolution Microendoscopy for the Management of Esophageal Neoplasia

用于治疗食管肿瘤的自动化增强现实高分辨率显微内窥镜检查

• 批准号: 9236004
• 负责人: Sharmila Anandasabapathy
• 金额: $ 49.74万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-17 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9236004
• 关键词: Area; Augmented Reality; Benign; Biopsy; Cell Nucleus; Cellular Phone; Characteristics; China; Chinese People; Clinical; Clinical Trials; Computer software; Cost Analysis; Devices; Diagnosis; Diagnostic; Disease model; Endoscopy; Epithelial; Epithelium; Esophageal; Esophageal Squamous Cell; Galaxy; Goals; Healthcare Systems; Human; Image; Image Analysis; Inflammation; Iodine; Light; Malignant Neoplasms; Malignant neoplasm of esophagus; Microscopic; Morphologic artifacts; Mucous Membrane; Neoplasms; Optical Biopsy; Optics; Performance; Procedures; Randomized Clinical Trials; Randomized Controlled Trials; Reproducibility; Research Infrastructure; Resolution; Resources; Screening for cancer; Severe dysplasia; Site; Specificity; Staining method; Stains; Surveillance Program; Survival Rate; System; Tablet Computer; Tablets; Time; Tissues; base; chemoradiation; chromoscopy; clinical decision-making; cost; cost effective; cost effectiveness; diagnostic accuracy; experience; global health; high risk population; imaging system; in vivo; innovation; mHealth; microendoscope; microendoscopy; microscopic imaging; mortality; neoplastic; outcome forecast; portability; prospective; screening; standard of care

Project Summary: 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. In an ongoing RO1 (2014-2019) of 1300 subjects in China and the USA, our group is evaluating a portable, battery-powered, high-resolution microendoscope that provides subcellular, 1100x-magnified images of the esophageal epithelium.This low-cost (< $1,500) device uses a Samsung Galaxy tablet computer to display microscopic epithelial images and image-analysis software to highlight abnormal nuclei allowing a more objective, real-time means of differentiating benign from neoplastic epithelium. In our current prospective, randomized, controlled trial of ESCN screening/surveillance, our goal is to determine whether this portable device increases the accuracy, diagnostic yield and clinical impact of routine endoscopic screening by providing a more objective, accurate, in vivo diagnosis that can direct a clinician’s decision to biopsy, not biopsy, or perform endoscopic therapy. The goal of this Revision R01 is to refine and validate a low-cost (HRME + glasses < $2,100) mobile, augmented reality (AR) platform that facilitates accurate, rapid, real-time endoscopic screening by non-expert clinicians worldwide. Using AR glasses and a small tablet computer (or cell phone), microendoscopic images with a quantitative, software interpretation (neoplasia vs. no neoplasia) will be displayed in real-time, colocalized with white light endoscopic images, allowing easier, more accurate biopsy and treatment.

项目摘要：尽管放化疗取得了进步，但食管癌的五年生存率 由于诊断已处于晚期且无法治愈，鳞状细胞瘤 (ESCN) 的发病率仍然高达 15%。 内窥镜筛查通常在高危人群中进行，对粘膜进行卢戈氏碘染色 以及异常（未染色）区域的针对性活检，而卢戈氏显着提高了白色的敏感性。 轻型内窥镜检查 (>95%)，由于炎症和其他良性粘膜变化，特异性仍然较差 (<65%) 虽然共聚焦显微内窥镜检查已被证明可以显着提高诊断能力。 Lugol 色素内窥镜的准确性和产量，现有平台价格昂贵（> 150,000 美元）并且只能使用 在全球少数几个高等教育中心。 在中国和美国正在进行的一项针对 1300 名受试者的 RO1（2014-2019）中，我们的小组正在评估一种便携式、 电池供电的高分辨率显微内窥镜，可提供 1100 倍放大的亚细胞图像 食管上皮细胞。这种低成本（< 1,500 美元）设备使用三星 Galaxy 平板电脑来显示 显微上皮图像和图像分析软件可突出显示异常细胞核，从而提供更多信息 在我们目前的前景中，区分良性上皮和肿瘤性上皮的客观、实时方法。 ESCN 筛查/监测的随机对照试验，我们的目标是确定这种便携式 设备通过以下方式提高常规内窥镜筛查的准确性、诊断率和临床影响 提供更客观、准确的体内诊断，可以指导临床医生进行活检的决定，而不是 活检或进行内窥镜治疗。 此修订版 R01 的目标是改进和验证低成本（HRME + 眼镜 < 2,100 美元）移动设备， 增强现实 (AR) 平台，有助于非专家进行准确、快速、实时的内窥镜筛查 使用 AR 眼镜和小型平板电脑（或手机），获取显微内窥镜图像。 通过定量软件解释（瘤形成与无瘤形成）将实时显示， 与白光内窥镜图像共定位，可以更轻松、更准确地进行活检和治疗。