In Vivo Confocal Microscopy Tumor Atlas Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Carl Zeiss Surgical GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Carl Zeiss Surgical GmbH
ClinicalTrials.gov Identifier:
NCT01012154
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 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 Microscopy Tumor Atlas Study

Resource links provided by NLM:


Further study details as provided by Carl Zeiss Surgical GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Capture usability and workflow aspects for the confocal device. [ Time Frame: During surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients Device: Endomicroscope
Endomicroscopic images and biopsies 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01012154

Contacts
Contact: Peter Nakaji, MD 602-406-4808

Locations
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
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: NCT01012154     History of Changes
Other Study ID Numbers: 002874
Study First Received: November 10, 2009
Last Updated: November 10, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014