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

January 7, 2016 updated by: Anandasabapathy, Sharmila, M.D.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • known or suspected squamous cell neoplasia
  • 18 years or older

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Proflavine hemisulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to determine whether or not tissue is neoplastic or non-neoplastic
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anandasabapathy, Sharmila, M.D.

Collaborators

William Marsh Rice University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO# 10-0982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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