Back to resultsEvaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Primary Purpose
Barrett's Esophagus
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proflavine Hemisulfate
Sponsored by
About this trial
This is an interventional screening trial for Barrett's Esophagus focused on measuring Barrett's esophagus, in vivo imaging, image guide microscope
Eligibility Criteria
Inclusion Criteria:
- Barrett's without dysplasia
- Barrett's with dysplasia
- Esophageal Adenocarcinoma
Exclusion Criteria:
- Subjects unfit for standard upper endoscopy
- Subjects currently receiving chemo or radiation treatment
- Subject currently receiving PDT or ablation
Sites / Locations
- Mount Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proflavine Hemisulfate
Arm Description
Outcomes
Primary Outcome Measures
To determine whether tissue is neoplastic or non-neoplastic
Secondary Outcome Measures
Full Information
NCT ID
NCT01384227
First Posted
June 21, 2011
Last Updated
January 8, 2016
Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT01384227
Brief Title
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Official Title
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in 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
Keywords
Barrett's esophagus, in vivo imaging, image guide microscope
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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proflavine Hemisulfate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Proflavine Hemisulfate
Other Intervention Name(s)
Proflavine
Intervention Description
Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)
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:
Barrett's without dysplasia
Barrett's with dysplasia
Esophageal Adenocarcinoma
Exclusion Criteria:
Subjects unfit for standard upper endoscopy
Subjects currently receiving chemo or radiation treatment
Subject currently receiving PDT or ablation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmila Anandasabapathy
Organizational Affiliation
Mt. Sinai School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26253018
Citation
Shin D, Lee MH, Polydorides AD, Pierce MC, Vila PM, Parikh ND, Rosen DG, Anandasabapathy S, Richards-Kortum RR. Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2016 Jan;83(1):107-14. doi: 10.1016/j.gie.2015.06.045. Epub 2015 Aug 5.
Results Reference
derived
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Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
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