A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

Anandasabapathy, Sharmila, M.D.

Status and phase: Terminated; Early Phase 1

Conditions: GERD; Barrett's Esophagus

Treatments: Drug: Fluorescein; Drug: Proflavine hemisulfate

Study type: Interventional

Identifiers

NCT01384695

GCO# 09-0696 Project 1

Details and patient eligibility

About

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient 18 years or older
• colonoscopy for screening or surveillance of polyps or disease of colon
• anoscopy because of suspected or known anal dysplasia or neoplasia

Exclusion criteria

• patient unable to provide informed consent
• patient found unfit for standard colonoscopy or anoscopy with biopsies

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Fluorescein

Experimental group

Description:

Confocal imaging using contrast agent fluorescein

Treatment:

Drug: Proflavine hemisulfate

Proflavine hemisulfate

Experimental group

Description:

confocal imaging using contrast agent proflavine

Treatment:

Drug: Fluorescein