Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia

The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or cancer). The investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a 'red flag' for microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of Barrett's esophagus.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Carcinoma Carcinoma in Situ Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Intraepithelial Neoplasia Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older
known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)

Exclusion criteria

Treatment and study plan

Proflavine

Drug

2-6 ml of 0.01% proflavine

Other names: Proflavine hemisulfate

Primary outcomes

to determine whether tissue is neoplastic or non-neoplastic

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Anandasabapathy, Sharmila, M.D.

Indiv

Collaborators

William Marsh Rice University

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Jun 29, 2011
Registry last updated: Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed