A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
Overview
- Phase
- Early Phase 1
- Intervention
- Proflavine hemisulfate
- Conditions
- GERD
- Sponsor
- Anandasabapathy, Sharmila, M.D.
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- to determine whether tissue is neoplastic or non-neoplastic
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Fluorescein
Confocal imaging using contrast agent fluorescein
Intervention: Proflavine hemisulfate
Proflavine hemisulfate
confocal imaging using contrast agent proflavine
Intervention: Fluorescein
Outcomes
Primary Outcomes
to determine whether tissue is neoplastic or non-neoplastic
Time Frame: 1 day