NCT01012154

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

Enrollment Period

1.1 years

First QC Date

November 10, 2009

Last Update Submit

November 10, 2009

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.

    One week

  • Capture usability and workflow aspects for the confocal device.

    During surgery

Study Arms (1)

All patients

EXPERIMENTAL
Device: Endomicroscope

Interventions

EndomicroscopeDEVICE

Endomicroscopic images and biopsies are taken at several positions on the tumor.

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy

You may not qualify if:

  • History of allergy to fluorescein
  • Patients on beta-blockers or ACE inhibitors
  • Pregnant women
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Phoenix, Arizona, 85013, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Peter Nakaji, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Nakaji, MD

CONTACT

602-406-4808

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 11, 2009

Record last verified: 2009-11

Locations

US(1)