In Vivo Confocal Endomicroscopy of the Brain

This study has been completed.
Sponsor:
Information provided by:
Carl Zeiss Surgical GmbH
ClinicalTrials.gov Identifier:
NCT00949793
First received: July 29, 2009
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Brain Neoplasms
Device: Endomicroscope
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In Vivo Confocal Endomicroscopy of the Brain

Resource links provided by NLM:


Further study details as provided by Carl Zeiss Surgical GmbH:

Primary Outcome Measures:
  • To test of the ability of the surgeon to obtain interpretable images during surgery. [ Time Frame: During surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate the in vivo endomicroscopy images with traditional histopathology. [ Time Frame: one week ] [ Designated as safety issue: No ]
  • To evaluate the usability of the device in the OR environment. [ Time Frame: During surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients Device: Endomicroscope
Endomicroscopic images are taken at several positions on the tumor.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949793

Locations
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
Investigators
Principal Investigator: Peter Nakaji, MD Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
  More Information

No publications provided

Responsible Party: Dr. Gerhard Gaida / Clinical Affairs, Carl Zeiss Surgical GmbH
ClinicalTrials.gov Identifier: NCT00949793     History of Changes
Other Study ID Numbers: 002441
Study First Received: July 29, 2009
Last Updated: November 9, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014