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

Anandasabapathy, Sharmila, M.D.

Status and phase: Completed; Early Phase 1

Conditions: Intraepithelial Neoplasia; Barrett's Esophagus

Treatments: Drug: proflavine

Study type: Interventional

Funder types: Other

Identifiers

NCT01384864

GCO# 09-0696 Project 3

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

treatment

Experimental group

Description:

fluorescent imaging with proflavine

Treatment:

Drug: proflavine