Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies (ASGE-FNDT-1)
|ClinicalTrials.gov Identifier: NCT00874263|
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : June 22, 2012
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.
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.
- To determine the initial sensitivity and specificity of confocal microendoscopy imaging for classification of adenomatous from hyperplastic polyps of the colon.
In this exploratory phase of the study to develop a library of confocal microendoscopic imaging characteristics of other GI pathologies such as:
- Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal squamous esophagus.
- 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.
|Condition or disease|
|Colonic Polyps Esophageal Diseases|
|Study Type :||Observational|
|Actual Enrollment :||225 participants|
|Official Title:||The Role of Endoscopic Confocal Microscopy in Diagnosing Colorectal Cancer and Other Gastrointestinal Pathologies in Vivo|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||June 2012|
- Endoscopic Confocal microscopy may help distinguish small adenomatous polyps with malignant potential from non-neoplastic (hyperplastic) polyps in real- time enabling immediate diagnosis and removal of only polyps with truly malignant potential. [ Time Frame: one year ]
- Endoscopic Confocal microscopy has the potential to fundamentally change the way endoscopy and pathology interact by allowing near histological-quality imaging in vivo, without the need, risk, and cost of tissue removal. [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874263
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Michael B Wallace, M.D.||Mayo Clinic Florida|