Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies

Completed

Conditions studied: Colonic Polyps, Esophageal Diseases

In brief

The recently developed endoscopic Confocal probe microscopy system allows imaging of surface epithelium during ongoing endoscopy (upper and lower) with the potential of immediate diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to determine if using this new Confocal probe system can find pre-cancerous abnormalities in the stomach and colon. Hypothesis: The confocal endomicroscopy images of colorectal lesions during the standard colonoscopies could help the classification in vivo of colorectal neoplastic and non-neoplastic lesions. This could direct further endoscopic interventions such as targeted biopsies of early colorectal cancer lesions and the endoscopic resection of such lesions during screening colonoscopies. Primary Aim 1. To determine the key confocal image features of neoplastic and pre-neoplastic colorectal lesions including flat and raised adenomatous polyps, intraepithelial neoplasia and cancer as well as benign lesions such as hyperplastic polyps and normal colonic epithelium and to estimate which morphologic features best distinguish neoplastic and non-neoplastic tissues. Secondary Aims: 2. To determine the initial sensitivity and specificity of confocal microendoscopy imaging for classification of adenomatous from hyperplastic polyps of the colon. 3. In this exploratory phase of the study to develop a library of confocal microendoscopic imaging characteristics of other GI pathologies such as: 1. Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal squamous esophagus. 2. Other encountered inflammatory and neoplastic conditions within the GI tract in which biopsy or removal of tissue would routinely be indicated. The second phase of the study will focus on establishing the sensitivities, specificities, accuracy of confocal images of colorectal lesions and other GI pathologies as well as inter-observer agreement and learning curve in interpretation of confocal images.

Key facts

Study ID

NCT00874263

Run by

Mayo Clinic

People needed

225

Starts

2008-03-01

Expected to finish

2012-06-01

Last updated by the study team

2012-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 18 to 100
• Any patient undergoing screening and/or surveillance colonoscopy and/or upper endoscopy with possible biopsy or removal of tissue by polypectomy

You may not qualify if…

• Unwilling to consent
• Allergy to fluorescein
• Lack of any pathological state that would require biopsy at the time of endoscopy (will be considered "screen failure" since this will not be known until after consent is obtained and sedated endoscopy performed)
• Women of child-bearing age who are sexually active and not practicing an acceptable form of contraception

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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