In Vivo Confocal Endomicroscopy of the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949793
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : November 10, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Device: Endomicroscope Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Confocal Endomicroscopy of the Brain
Study Start Date : March 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: All patients Device: Endomicroscope
Endomicroscopic images are taken at several positions on the tumor.

Primary Outcome Measures :
  1. To test of the ability of the surgeon to obtain interpretable images during surgery. [ Time Frame: During surgery ]

Secondary Outcome Measures :
  1. To correlate the in vivo endomicroscopy images with traditional histopathology. [ Time Frame: one week ]
  2. To evaluate the usability of the device in the OR environment. [ Time Frame: During surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00949793

United States, Arizona
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
Carl Zeiss Surgical GmbH
Principal Investigator: Peter Nakaji, MD Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

Responsible Party: Dr. Gerhard Gaida / Clinical Affairs, Carl Zeiss Surgical GmbH Identifier: NCT00949793     History of Changes
Other Study ID Numbers: 002441
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Carl Zeiss Surgical GmbH:
Microscopy, Confocal
Microscopy, Fluorescence
Intraoperative Procedures

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases