In Vivo Confocal Microscopy Tumor Atlas Study
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|ClinicalTrials.gov Identifier: NCT01012154|
Recruitment Status : Unknown
Verified November 2009 by Carl Zeiss Surgical GmbH.
Recruitment status was: Recruiting
First Posted : November 11, 2009
Last Update Posted : November 11, 2009
|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. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.
In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Vivo Confocal Microscopy Tumor Atlas Study|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
|Experimental: All patients||
Endomicroscopic images and biopsies are taken at several positions on the tumor.
- Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site‐matched biopsies across a range of tumor types and grades. [ Time Frame: During surgery ]
- Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo. [ Time Frame: One week ]
- Capture usability and workflow aspects for the confocal device. [ 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): NCT01012154
|Contact: Peter Nakaji, MD||602-406-4808|
|United States, Arizona|
|Barrow Neurological Institute, St. Joseph's Hospital and Medical Center||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator: Peter Nakaji, MD|
|Sub-Investigator: Robert F Spetzler, MD|
|Sub-Investigator: Kris Smith, MD|
|Sub-Investigator: Jennifer Eschbacher, MD|
|Principal Investigator:||Peter Nakaji, MD||Barrow Neurological Institute, St. Joseph's Hospital and Medical Center|