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

This study is currently recruiting participants.
Verified June 2013 by Anandasabapathy, Sharmila, M.D.
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384708
First received: June 28, 2011
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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
 Phase 0

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • known or suspected squamous cell neoplasia
  • 18 years or older
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384708

Locations
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Josie Mitcham     212-241-6293     josephine.mitcham@mountsinai.org    
Contact: sharmila anandasabapathy, MD     212-241-7535     sharmila.anandasabapathy@mountsinai.org    
Principal Investigator: Sharmila Anandasabapathy, MD            
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
William Marsh Rice University
  More Information

No publications provided

Responsible Party: Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT01384708     History of Changes
Other Study ID Numbers: GCO# 10-0982
Study First Received: June 28, 2011
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013