Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
This study is currently recruiting participants.
Verified September 2011 by Anandasabapathy, Sharmila, M.D.
Sponsor:
Anandasabapathy, Sharmila, M.D.
Collaborator:
William Marsh Rice University
Information provided by:
Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384864
First received: June 28, 2011
Last updated: September 30, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Barrett's Esophagus Intraepithelial Neoplasia |
Drug: proflavine |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia |
Resource links provided by NLM:
Further study details as provided by Anandasabapathy, Sharmila, M.D.:
Primary Outcome Measures:
- to determine whether tissue is neoplastic or non-neoplastic [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment
fluorescent imaging with proflavine
|
Drug: proflavine
2-6 ml of 0.01% proflavine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or older
- known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)
Exclusion Criteria:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384864
Locations
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: sharmila anandasabapathy, MD 212-241-7535 sharmila.anandasabapathy@mountsinai.org | |
| Contact: josephine Mitcham 212-241-6293 josephine.mitcham@mountsinia.org | |
| Principal Investigator: Sharmila anandasabapathy, MD | |
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
William Marsh Rice University
More Information
No publications provided
| Responsible Party: | Sharmila Anandasabapathy, MD |
| ClinicalTrials.gov Identifier: | NCT01384864 History of Changes |
| Other Study ID Numbers: | GCO# 09-0696 Project 3 |
| Study First Received: | June 28, 2011 |
| Last Updated: | September 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anandasabapathy, Sharmila, M.D.:
|
barrett's esophagus intraepithelial neoplasia cross polarized reflectance examination vital-dye enhanced fluorescence examination |
Additional relevant MeSH terms:
|
Barrett Esophagus Neoplasms Carcinoma in Situ Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Proflavine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013