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

NCT ID: NCT01384864

Last Updated: 2016-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Barrett's Esophagus Intraepithelial Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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treatment

fluorescent imaging with proflavine

Group Type EXPERIMENTAL

proflavine

Intervention Type DRUG

2-6 ml of 0.01% proflavine

Interventions

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proflavine

2-6 ml of 0.01% proflavine

Intervention Type DRUG

Other Intervention Names

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Proflavine hemisulfate

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Marsh Rice University

OTHER

Sponsor Role collaborator

Anandasabapathy, Sharmila, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mount Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO# 09-0696 Project 3

Identifier Type: -

Identifier Source: org_study_id

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