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

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