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In Vivo Confocal Endomicroscopy of the Brain

Primary Purpose

Brain Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endomicroscope
Sponsored by
Carl Zeiss Surgical GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Neoplasms focused on measuring Pathology, Microscopy, Confocal, Microscopy, Fluorescence, Intraoperative Procedures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy.

Exclusion Criteria:

  • Pregnant women
  • Inability to give informed consent
  • History of allergy to fluorescein
  • Patients on beta-blockers or ACE inhibitors

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

Outcomes

Primary Outcome Measures

To test of the ability of the surgeon to obtain interpretable images during surgery.

Secondary Outcome Measures

To correlate the in vivo endomicroscopy images with traditional histopathology.
To evaluate the usability of the device in the OR environment.

Full Information

First Posted
July 29, 2009
Last Updated
November 9, 2009
Sponsor
Carl Zeiss Surgical GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00949793
Brief Title
In Vivo Confocal Endomicroscopy of the Brain
Official Title
In Vivo Confocal Endomicroscopy of the Brain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Carl Zeiss Surgical GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology. Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.
Detailed Description
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery. The procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
Pathology, Microscopy, Confocal, Microscopy, Fluorescence, Intraoperative Procedures

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endomicroscope
Intervention Description
Endomicroscopic images are taken at several positions on the tumor.
Primary Outcome Measure Information:
Title
To test of the ability of the surgeon to obtain interpretable images during surgery.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
To correlate the in vivo endomicroscopy images with traditional histopathology.
Time Frame
one week
Title
To evaluate the usability of the device in the OR environment.
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy. Exclusion Criteria: Pregnant women Inability to give informed consent History of allergy to fluorescein Patients on beta-blockers or ACE inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Nakaji, MD
Organizational Affiliation
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States

12. IPD Sharing Statement

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In Vivo Confocal Endomicroscopy of the Brain

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