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.

Public Health Relevance

Esophageal cancer is a major global health problem and carries a poor prognosis when diagnosed at a late stage. Here we propose an innovative, cost-effective mobile health platform for enhancing the accuracy and reproducibility of endoscopic screening in low-resource regions.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
3R01CA181275-03S1
Application #
9236004
Study Section
Medical Imaging Study Section (MEDI)
Program Officer
Baker, Houston
Project Start
2014-09-17
Project End
2018-08-31
Budget Start
2016-09-01
Budget End
2017-08-31
Support Year
3
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Baylor College of Medicine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
Quang, Timothy; Schwarz, Richard A; Dawsey, Sanford M et al. (2016) A tablet-interfaced high-resolution microendoscope with automated image interpretation for real-time evaluation of esophageal squamous cell neoplasia. Gastrointest Endosc 84:834-841
Hur, Chin; Choi, Sung Eun; Kong, Chung Yin et al. (2015) High-resolution microendoscopy for esophageal cancer screening in China: A cost-effectiveness analysis. World J Gastroenterol 21:5513-23
Protano, Marion-Anna; Xu, Hong; Wang, Guiqi et al. (2015) Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial. Gastroenterology 149:321-329
Louie, Justin S; Richards-Kortum, Rebecca; Anandasabapathy, Sharmila (2014) Applications and advancements in the use of high-resolution microendoscopy for detection of gastrointestinal neoplasia. Clin Gastroenterol Hepatol 12:1789-92