Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon

NCT03220711 | Terminated DMC

• 1 other identifier: HUM00124968
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this research project is to evaluate the imaging performance of a confocal endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group. This endomicroscope probe will be used during colonoscopies in subjects with colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).

Conditions

Colonic Dysplasia; Adenomatous Polyps; Irritable Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Depth-imaging capability of the confocal endomicroscope using an imaging contrast agent, fluorescein

  The test product efficacy will be assessed by evaluating the fluorescence intensities measured from suspicious regions of colonic mucosa where the agent is administered compared to adjacent normal mucosa.

  five minutes

Study Arms (1)

Subjects with abnormal colon tissue

EXPERIMENTAL

The study subjects will be high-risk for colonic adenomas (i.e. strong family history of adenomas/adenocarcinoma or personal history of adenomas/adenocarcinoma), known adenoma scheduled for endoscopic resection, or in subjects with suspected dysplasia in inflammatory bowel disease (IBD). Fluorescein will be sprayed on the area of interest to provide imaging contrast for the images taken with the confocal endomicroscope.

Device: confocal endomicroscope; Drug: Fluorescein

Interventions

confocal endomicroscope DEVICE

This instrument provides real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group during colonoscopies.

Subjects with abnormal colon tissue

Fluorescein DRUG

Fluorescent dye used for imaging contrast only.

Also known as: Fluorescite

Subjects with abnormal colon tissue

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject meets at least one of the following criteria:
• At increased risk for colorectal cancer and colonic polyps
• Known colonic adenomas scheduled for colonic polyp resection
• Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia.

You may not qualify if:

• Subject meets all of the following criteria:
• Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at University of Michigan Health System.
• Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study.
• Age 18 to 100 years
• Willing and able to sign informed consent

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Adenomatous Polyps; Irritable Bowel Syndrome

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Danielle Kim Turgeon, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine and Clinical Track Faculty Ombuds, Medical School

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: July 28, 2017
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

US (1)