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NCT01384864 Clinical Trial

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

Barrett's Esophagus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01384864
Other study ID # GCO# 09-0696 Project 3
Secondary ID
Status Completed
Phase Phase 0
First received June 28, 2011
Last updated January 7, 2016
Start date August 2011
Est. completion date December 2015

Study information
Verified date January 2016
Source Anandasabapathy, Sharmila, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• proflavine
2-6 ml of 0.01% proflavine

Locations
Country Name City State
United States Mount Sinai School of Medicine New York New York

Sponsors (2)
Lead Sponsor Collaborator
Anandasabapathy, Sharmila, M.D. William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to determine whether tissue is neoplastic or non-neoplastic 1 day No
See also
  Status Clinical Trial Phase
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Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
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Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
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Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Not yet recruiting NCT02033070 - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A