In Vivo Confocal Microscopy Tumor Atlas Study
Recruitment status was Recruiting
This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site‐matched biopsies.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||In Vivo Confocal Microscopy Tumor Atlas Study|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Capture usability and workflow aspects for the confocal device. [ Time Frame: During surgery ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: All patients||
Endomicroscopic images and biopsies 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. 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|