NCT00233350

Brief Summary

3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is started for the evaluation of this tool as a means for achieving total resection of brain tumors at greater safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

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

First Submitted

Initial submission to the registry

October 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 1, 2015

Status Verified

October 1, 2012

Enrollment Period

2.9 years

First QC Date

October 4, 2005

Last Update Submit

September 30, 2015

Conditions

Brain Neoplasms

Keywords

NeuronavigationUltrasoundBrain tumour surgeryBiopsyHistopathologyIntraoperative imaging3D ultrasound imaging

Interventions

use of navigated 3D ultrasound during surgeryDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who were operated for intracranial high-grade gliomas (World Health Organisation(WHO) grade III/IV) in the 3-year period between January 1st 2007 and December 31st 2009 in the Department of Neurosurgery, St. Olavs University Hospital, Trondheim, Norway

You may qualify if:

  • Supratentorial glioma

You may not qualify if:

  • Not willing to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • Solheim O, Selbekk T, Jakola AS, Unsgard G. Ultrasound-guided operations in unselected high-grade gliomas--overall results, impact of image quality and patient selection. Acta Neurochir (Wien). 2010 Nov;152(11):1873-86. doi: 10.1007/s00701-010-0731-5. Epub 2010 Jul 21.

    PMID: 20652608RESULT

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Geirmund Unsgaard, MD, PhD

    National Taiwan Normal University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 5, 2005

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 1, 2015

Record last verified: 2012-10

Locations

NO(1)