A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
Overview
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.
Full Title of Study: “A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia – Project 1”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Screening
- Masking: None (Open Label)
- Study Primary Completion Date: February 2014
Interventions
- Drug: Fluorescein
- fluorescent contrast agent, Fluorescein 5ml
- Drug: Proflavine hemisulfate
- 3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
Arms, Groups and Cohorts
- Experimental: Fluorescein
- Confocal imaging using contrast agent fluorescein
- Experimental: Proflavine hemisulfate
- confocal imaging using contrast agent proflavine
Clinical Trial Outcome Measures
Primary Measures
- to determine whether tissue is neoplastic or non-neoplastic
- Time Frame: 1 day
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Anandasabapathy, Sharmila, M.D.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Sharmila Anandasabapathy, M.D., Principal Investigator, Mt. Sinai School of Medicine
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.