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Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer

This study has been completed.
William Marsh Rice University
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D. Identifier:
First received: June 28, 2011
Last updated: January 7, 2016
Last verified: March 2014
The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides > 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.

Condition Intervention Phase
Squamous Cell Cancer
Drug: proflavine
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer

Resource links provided by NLM:

Further study details as provided by Anandasabapathy, Sharmila, M.D.:

Primary Outcome Measures:
  • to determine whether or not tissue is neoplastic or non-neoplastic [ Time Frame: 1 day ]

Enrollment: 70
Study Start Date: August 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
imaging with proflavine
Drug: proflavine
1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)
Other Name: Proflavine hemisulfate


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • known or suspected squamous cell neoplasia
  • 18 years or older
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Please refer to this study by its identifier: NCT01384708

United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
William Marsh Rice University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anandasabapathy, Sharmila, M.D. Identifier: NCT01384708     History of Changes
Other Study ID Numbers: GCO# 10-0982
Study First Received: June 28, 2011
Last Updated: January 7, 2016

Keywords provided by Anandasabapathy, Sharmila, M.D.:
squamous cell cancer
squamous cell neoplasia

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anti-Infective Agents, Local
Anti-Infective Agents processed this record on April 28, 2017