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

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.

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Key information

Conditions

Squamous Cell Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mount Sinai Medical Center

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

known or suspected squamous cell neoplasia
18 years or older

Treatment and study plan

Proflavine

Drug

1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)

Other names: Proflavine hemisulfate

Primary outcomes

to determine whether or not tissue is neoplastic or non-neoplastic

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Anandasabapathy, Sharmila, M.D.

Indiv

Collaborators

William Marsh Rice University

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jun 29, 2011
Registry last updated: Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed