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In Vivo Confocal Microscopy Tumor Atlas Study


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Brain Neoplasms

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Trial Information

In Vivo Confocal Microscopy Tumor Atlas Study


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

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:

002874

NCT ID:

NCT01012154

Start Date:

November 2009

Completion Date:

December 2010

Related Keywords:

  • Brain Neoplasms
  • Brain Neoplasms
  • Neoplasms

Name

Location

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