In Vivo Confocal Endomicroscopy of the Brain
The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology.
Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||In Vivo Confocal Endomicroscopy of the Brain|
- To test of the ability of the surgeon to obtain interpretable images during surgery. [ Time Frame: During surgery ] [ Designated as safety issue: No ]
- To correlate the in vivo endomicroscopy images with traditional histopathology. [ Time Frame: one week ] [ Designated as safety issue: No ]
- To evaluate the usability of the device in the OR environment. [ Time Frame: During surgery ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Experimental: All patients||
Endomicroscopic images are taken at several positions on the tumor.
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery.
The procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949793
|United States, Arizona|
|Barrow Neurological Institute, St. Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator:||Peter Nakaji, MD||Barrow Neurological Institute, St. Joseph's Hospital and Medical Center|