In Vivo Confocal Endomicroscopy of the Brain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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In Vivo Confocal Endomicroscopy of the Brain

Conditions
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Brain Neoplasms

Intervention / Treatment
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* Device: Endomicroscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy. Exclusion Criteria: Pregnant women Inability to give informed consent History of allergy to fluorescein Patients on beta-blockers or ACE inhibitors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br> | Device: Endomicroscope<br>* Endomicroscopic images are taken at several positions on the tumor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test of the ability of the surgeon to obtain interpretable images during surgery. |  | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the in vivo endomicroscopy images with traditional histopathology. |  | one week | 
| To evaluate the usability of the device in the OR environment. |  | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pathology, Microscopy, Confocal, Microscopy, Fluorescence, Intraoperative Procedures