In Vivo Confocal Microscopy Tumor Atlas Study

NCT ID: NCT01012154

Last Updated: 2009-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-12-31

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.

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.

Conditions

Brain Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All patients

Group Type: EXPERIMENTAL

Endomicroscope

Intervention Type: DEVICE

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

Interventions

Endomicroscope

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Surgical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Carl Zeiss Surgical GmbH

Principal Investigators

Peter Nakaji, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Phoenix, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Peter Nakaji, MD

Role: CONTACT

602-406-4808

Other Identifiers

002874

Identifier Type: -

Identifier Source: org_study_id