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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01384864

Enrollment

Registered

2011-06-29

Start date

2011-08-31

Completion date

2015-12-31

Last updated

2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus, Intraepithelial Neoplasia

Keywords

barrett's esophagus, intraepithelial neoplasia, cross polarized reflectance examination, vital-dye enhanced fluorescence examination

Brief summary

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.

Interventions

DRUGproflavine

2-6 ml of 0.01% proflavine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
to determine whether tissue is neoplastic or non-neoplastic	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026