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

NCT ID: NCT01384708

Last Updated: 2016-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Squamous Cell Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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treatment

imaging with proflavine

Group Type EXPERIMENTAL

proflavine

Intervention Type DRUG

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

Interventions

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proflavine

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

Intervention Type DRUG

Other Intervention Names

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Proflavine hemisulfate

Eligibility Criteria

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Inclusion Criteria

* known or suspected squamous cell neoplasia
* 18 years or older
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Marsh Rice University

OTHER

Sponsor Role collaborator

Anandasabapathy, Sharmila, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mount Sinai Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Protano MA, Xu H, Wang G, Polydorides AD, Dawsey SM, Cui J, Xue L, Zhang F, Quang T, Pierce MC, Shin D, Schwarz RA, Bhutani MS, Lee M, Parikh N, Hur C, Xu W, Moshier E, Godbold J, Mitcham J, Hudson C, Richards-Kortum RR, Anandasabapathy S. Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial. Gastroenterology. 2015 Aug;149(2):321-329. doi: 10.1053/j.gastro.2015.04.055. Epub 2015 May 14.

Reference Type DERIVED
PMID: 25980753 (View on PubMed)

Other Identifiers

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GCO# 10-0982

Identifier Type: -

Identifier Source: org_study_id

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