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

November 10, 2009
November 10, 2009
November 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
In Vivo Confocal Microscopy Tumor Atlas Study
In Vivo Confocal Microscopy Tumor Atlas Study

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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Brain Neoplasms
Device: Endomicroscope
Endomicroscopic images and biopsies are taken at several positions on the tumor.
Experimental: All patients
Intervention: Device: Endomicroscope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Peter Nakaji, MD 602-406-4808
United States
 
NCT01012154
002874
No
Dr. Gerhard Gaida / Clinical Affairs, Carl Zeiss Surgical GmbH
Carl Zeiss Surgical GmbH
Not Provided
Principal Investigator: Peter Nakaji, MD Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Carl Zeiss Surgical GmbH
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP