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

Study Overview
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Brief Summary
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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).

Detailed Description
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The device is being tested in small groups of individuals: generally less than 10 for each of a variety of histologically different colonic lesions or diseases (eg. IBD, adenomas, sessile seriated adenomas (SSAs), hyperplastic polyps, normal tissue).

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

Conditions
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Colonic Dysplasia, Adenomatous Polyps, Irritable Bowel Disease

Intervention / Treatment
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* Device: confocal endomicroscope
* Drug: Fluorescein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with abnormal colon tissue<br>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<br>* This instrument provides real-time endoscopic histology to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group during colonoscopies.<br>Drug: Fluorescein<br>* Fluorescent dye used for imaging contrast only.<br>* Other names: Fluorescite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |