NCT00949793

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

1.7 years

First QC Date

July 29, 2009

Last Update Submit

November 9, 2009

Conditions

Brain Neoplasms

Keywords

PathologyMicroscopy, ConfocalMicroscopy, FluorescenceIntraoperative Procedures

Outcome Measures

Primary Outcomes (1)

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

    During surgery

Secondary Outcomes (2)

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

    one week

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

    During surgery

Study Arms (1)

All patients

EXPERIMENTAL
Device: Endomicroscope

Interventions

EndomicroscopeDEVICE

Endomicroscopic images 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 neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy.

You may not qualify if:

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

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

Location

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

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

July 29, 2009

First Posted

July 30, 2009

Study Start

March 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

US(1)