In Vivo Confocal Endomicroscopy of the Brain

Brain Neoplasms Clinical Trial

Official title:

In Vivo Confocal Endomicroscopy of the Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949793
• Other study ID #: 002441
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2009
• Last updated: November 9, 2009
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Carl Zeiss Surgical GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Device:
• Endomicroscope
Endomicroscopic images are taken at several positions on the tumor.

Locations

Country	Name	City	State
United States	Barrow Neurological Institute, St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Surgical GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test of the ability of the surgeon to obtain interpretable images during surgery.		During surgery	No
Secondary	To correlate the in vivo endomicroscopy images with traditional histopathology.		one week	No
Secondary	To evaluate the usability of the device in the OR environment.		During surgery	No