Recruiting
Phase 1

Confocal Endomicroscopy

Sponsor:

Carl Zeiss Surgical GmbH

Code:

NCT01012154

Conditions

Brain Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endomicroscope

Study Details

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.

Conditions

Brain Neoplasms

Study ID

NCT01012154

Start date

Nov, 2009

Status verified date

Nov, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: All patients

Interventions

Endomicroscope

Endomicroscopic images and biopsies are taken at several positions on the tumor.

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 ]

Central Contacts and Locations

Central contacts

Peter Nakaji, MD

602-406-4808

Locations

Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Principal Investigator:

Peter Nakaji, MD

More Information

Sponsor

Carl Zeiss Surgical GmbH

Last update posted

Nov 11, 2009

Last verified

Nov, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carl Zeiss Surgical GmbH on 2009-11-11.