Despite advances in chemoradiation therapy, the 5-year survival rate from esophageal squamous cell cancer (SCC) 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 standard white-light endoscopy, specificity remains poor as inflammation and other benign mucosal changes can mimic neoplasia. While high-resolution imaging with confocal endomicroscopy has been shown to dramatically enhance the diagnostic accuracy and yield of Lugol's chromoendoscopy and other widefield techniques, existing platforms are costly (>$150,000) and only available in a handful of tertiary centers worldwide. Our group has developed a low-cost, portable, battery-operated high-resolution microendoscope (HRME) that can provide subcellular images of the esophageal epithelium and delineate the cellular and morphologic changes associated with neoplasia. Our central hypothesis is that this low-cost imaging device will increase the efficiency and yield of current endoscopic screening practices by offering a real-time, in vivo diagnosis ('optical biopsy') in clinically indeterminate areas. This will allow for more selective (i.e. targeted) biopsies and will offer the potential for immediate clinical decision- making. To determine this, we will conduct a clinical trial of the device in high-risk subjects undergoing endoscopic screening for suspected squamous cell neoplasia in both the United States and northern China. Specifically, we will determine (a) the diagnostic accuracy (sensitivity and specificity) of the HRME for the in vivo diagnosis of esophageal squamous neoplasia, and (b) the diagnostic yield and potential clinical impact of the HRME in this population. Successful results can easily be translated to other organ systems (skin, colon, cervix, etc.).

Public Health Relevance

Esophageal cancer is a major global health problem and carries a poor prognosis when diagnosed at a late stage. The improved identification of early neoplasia offers the greatest opportunity to reduce morbidity and mortality worldwide.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21CA156704-02
Application #
8329629
Study Section
Special Emphasis Panel (ZRG1-SBIB-V (56))
Program Officer
Tandon, Pushpa
Project Start
2011-09-07
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
2
Fiscal Year
2012
Total Cost
$324,173
Indirect Cost
$71,346
Name
Icahn School of Medicine at Mount Sinai
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
Shin, Dongsuk; Protano, Marion-Anna; Polydorides, Alexandros D et al. (2015) Quantitative analysis of high-resolution microendoscopic images for diagnosis of esophageal squamous cell carcinoma. Clin Gastroenterol Hepatol 13:272-279.e2
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
Richards-Kortum, Rebecca; Oden, Maria (2013) Engineering. Devices for low-resource health care. Science 342:1055-7