In Vivo Confocal Microscopy Tumor Atlas Study

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: NCT01012154
Recruitment Status : Unknown
Verified November 2009 by Carl Zeiss Surgical GmbH.
Recruitment status was:  Recruiting
First Posted : November 11, 2009
Last Update Posted : November 11, 2009
Information provided by:
Carl Zeiss Surgical GmbH

Brief Summary:
This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site‐matched biopsies.

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. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.

In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Confocal Microscopy Tumor Atlas Study
Study Start Date : November 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site‐matched biopsies across a range of tumor types and grades. [ Time Frame: During surgery ]

Secondary Outcome Measures :
  1. Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo. [ Time Frame: One week ]
  2. Capture usability and workflow aspects for the confocal device. [ 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 neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy

Exclusion Criteria:

  • History of allergy to fluorescein
  • Patients on beta‐blockers or ACE inhibitors
  • Pregnant women
  • Inability to give informed consent

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): NCT01012154

Contact: Peter Nakaji, MD 602-406-4808

United States, Arizona
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Principal Investigator: Peter Nakaji, MD         
Sub-Investigator: Robert F Spetzler, MD         
Sub-Investigator: Kris Smith, MD         
Sub-Investigator: Jennifer Eschbacher, MD         
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: NCT01012154     History of Changes
Other Study ID Numbers: 002874
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009

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