In Vivo Confocal Microscopy Tumor Atlas Study

November 10, 2009 updated by: Carl Zeiss Surgical GmbH
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peter Nakaji, MD
  • Phone Number: 602-406-4808

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
        • Principal Investigator:
          • Peter Nakaji, MD
        • Sub-Investigator:
          • Robert F Spetzler, MD
        • Sub-Investigator:
          • Jennifer Eschbacher, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: All patients
Endomicroscopic images and biopsies are taken at several positions on the tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
One week
Capture usability and workflow aspects for the confocal device.
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (ESTIMATE)

November 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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