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In Vivo Confocal Endomicroscopy of the Brain


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms

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Trial Information

In Vivo Confocal Endomicroscopy of the Brain


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

During surgery

Safety Issue:

No

Principal Investigator

Peter Nakaji, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

002441

NCT ID:

NCT00949793

Start Date:

March 2008

Completion Date:

November 2009

Related Keywords:

  • Brain Neoplasms
  • Pathology
  • Microscopy, Confocal
  • Microscopy, Fluorescence
  • Intraoperative Procedures
  • Brain Neoplasms
  • Neoplasms

Name

Location

Barrow Neurological Institute, St. Joseph's Hospital and Medical Center Phoenix, Arizona  85013