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Completed

NCT Number: NCT00949793

In Vivo Confocal Endomicroscopy of the Brain

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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Phoenix, Arizona, 85013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endomicroscope

Device

Endomicroscopic images are taken at several positions on the tumor.

Primary outcomes

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

    Time frame: During surgery

Secondary outcomes

  1. To correlate the in vivo endomicroscopy images with traditional histopathology.

    Time frame: one week

  2. To evaluate the usability of the device in the OR environment.

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

Carl Zeiss Surgical GmbH

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 30, 2009
Registry last updated
Nov 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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