In Vivo Confocal Endomicroscopy of the Brain
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|ClinicalTrials.gov Identifier: NCT00949793|
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : November 10, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms||Device: Endomicroscope||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Vivo Confocal Endomicroscopy of the Brain|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
|Experimental: All patients||
Endomicroscopic images are taken at several positions on the tumor.
- To test of the ability of the surgeon to obtain interpretable images during surgery. [ Time Frame: During surgery ]
- To correlate the in vivo endomicroscopy images with traditional histopathology. [ Time Frame: one week ]
- To evaluate the usability of the device in the OR environment. [ Time Frame: During surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|