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

项目总结：尽管放化疗治疗取得了进展，但食管癌的5年生存率仍然很低， 鳞状细胞瘤（ESCN）由于诊断为晚期不可治愈的阶段，仍然只有15%。 内窥镜筛查通常在高危人群中进行，并对粘膜进行卢戈碘染色 以及异常（未染色）区域的靶向活检。而卢戈氏染色显著增加了对白色的敏感性， 光内镜检查（>95%），特异性仍然很差（<65%），如炎症和其他良性粘膜变化 类似瘤形成虽然共聚焦显微内窥镜已被证明可以显着提高诊断 由于Lugol的色素内镜的准确性和产量，现有的平台是昂贵的（> 150，000美元），并且只能在 在世界各地的一些第三中心。 在中国和美国1300名受试者的持续RO 1（2014-2019）中，我们的团队正在评估一种便携式， 电池供电，高分辨率显微内窥镜，提供亚细胞，1100倍放大的图像， 食管上皮。这种低成本（<1,500美元）的设备使用三星Galaxy平板电脑显示 显微镜上皮图像和图像分析软件，以突出异常细胞核，允许更多的 客观、实时的手段来区分良性上皮和肿瘤上皮。在我们目前的前景中， 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 该器械通过以下方式提高了常规内镜筛查的准确性、诊断率和临床影响： 提供更客观、准确的体内诊断，可以指导临床医生决定活检， 活检或进行内窥镜治疗。 本修订版R 01的目标是改进和验证低成本（HRME +眼镜<2，100美元）移动的， 增强现实（AR）平台，便于非专家进行准确、快速、实时的内窥镜筛查 世界各地的临床医生使用AR眼镜和小型平板电脑（或手机），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， 与白色光内窥镜图像共定位，允许更容易、更准确的活检和治疗。

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.