Back to resultsEndoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
Primary Purpose
Barrett's Esophagus, Intraepithelial Neoplasia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
proflavine
Sponsored by
About this trial
This is an interventional screening trial for Barrett's Esophagus focused on measuring barrett's esophagus, intraepithelial neoplasia, cross polarized reflectance examination, vital-dye enhanced fluorescence examination
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)
Exclusion Criteria:
-
Sites / Locations
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
fluorescent imaging with proflavine
Outcomes
Primary Outcome Measures
to determine whether tissue is neoplastic or non-neoplastic
Secondary Outcome Measures
Full Information
NCT ID
NCT01384864
First Posted
June 28, 2011
Last Updated
January 7, 2016
Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
William Marsh Rice University
1. Study Identification
Unique Protocol Identification Number
NCT01384864
Brief Title
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
Official Title
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
William Marsh Rice University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, Intraepithelial Neoplasia
Keywords
barrett's esophagus, intraepithelial neoplasia, cross polarized reflectance examination, vital-dye enhanced fluorescence examination
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
fluorescent imaging with proflavine
Intervention Type
Drug
Intervention Name(s)
proflavine
Other Intervention Name(s)
Proflavine hemisulfate
Intervention Description
2-6 ml of 0.01% proflavine
Primary Outcome Measure Information:
Title
to determine whether tissue is neoplastic or non-neoplastic
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)
Exclusion Criteria:
-
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
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