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

This study has been completed.
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384864
First received: June 28, 2011
Last updated: January 7, 2016
Last verified: January 2016
  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 ]

Enrollment: 30
Study Start Date: August 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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
Other Name: Proflavine hemisulfate

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 28, 2011
Last Updated: January 7, 2016
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:
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

ClinicalTrials.gov processed this record on September 23, 2016