In Vivo Confocal Microscopy Tumor Atlas Study

Brain Neoplasms Clinical Trial

Official title:

In Vivo Confocal Microscopy Tumor Atlas Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01012154
• Other study ID #: 002874
• Status: Recruiting
• Phase: Phase 1
• First received: November 10, 2009
• Last updated: November 10, 2009
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2009
• Source: Carl Zeiss Surgical GmbH
• Contact: Peter Nakaji, MD
• Phone: 602-406-4808
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site‐matched biopsies.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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 and biopsies 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	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.		During surgery	No
Secondary	Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.		One week	No
Secondary	Capture usability and workflow aspects for the confocal device.		During surgery	No