In Vivo Confocal Endomicroscopy of the Brain

NCT ID: NCT00949793

Last Updated: 2009-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-11-30

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.

Conditions

Brain Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All patients

Group Type: EXPERIMENTAL

Endomicroscope

Intervention Type: DEVICE

Endomicroscopic images are taken at several positions on the tumor.

Interventions

Endomicroscope

Endomicroscopic images are taken at several positions on the tumor.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Surgical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Carl Zeiss Surgical GmbH

Principal Investigators

Peter Nakaji, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

Locations

Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

002441

Identifier Type: -

Identifier Source: org_study_id