In Vivo Confocal Endomicroscopy of the Brain

Phase 1

Completed

• Conditions: Brain Neoplasms
• Interventions: Device: Endomicroscope

• Registration Number: NCT00949793
• Lead Sponsor: Carl Zeiss Surgical GmbH

Brief Summary

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

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Endomicroscope	-

Primary Outcome Measures

Name	Time	Method
To test of the ability of the surgeon to obtain interpretable images during surgery.	During surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Barrow Neurological Institute, St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States