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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01384864
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : January 11, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Intraepithelial Neoplasia Drug: proflavine Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
Study Start Date : August 2011
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: treatment
fluorescent imaging with proflavine
Drug: proflavine
2-6 ml of 0.01% proflavine
Other Name: Proflavine hemisulfate


Outcome Measures

Primary Outcome Measures :
  1. to determine whether tissue is neoplastic or non-neoplastic [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384864


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
William Marsh Rice University
More Information

Responsible Party: Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT01384864     History of Changes
Other Study ID Numbers: GCO# 09-0696 Project 3
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

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:
Neoplasms
Barrett Esophagus
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