Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors

Not Applicable

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Device: Stealth Station; Device: PoleStar N20

• Registration Number: NCT00943007
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged survival. The standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. However, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". This is caused by edema, loss of cerebrospinal fluid and tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for brain shift, and to check for the presence of residual tumor that can be removed.

This study aims to compare the extent of glioblastoma resection between the standard treatment and intraoperative MRI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-20
• Study First Posted: 2009-07-21
• Study Start: 2010-02
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• supratentorial brain tumor, on contrast enhanced dMRI suspected to be GBM
• indication for gross total resection (GTR) of the tumor
• age ≥18 years
• WHO Performance Scale ≤ 2
• ASA class ≤ 3
• adequate knowledge of the Dutch or French language
• informed consent

Exclusion Criteria

• recurrent brain tumor
• multiple brain tumor localizations
• earlier skull radiotherapy
• earlier chemotherapy for GBM
• Chronic Kidney Disease or other renal function disorder
• known MR-contrast allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Neuronavigation	Stealth Station	Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
Intraoperative MRI	PoleStar N20	Standard neuronavigation plus intraoperative MRI to correct for brain shift

Primary Outcome Measures

Name	Time	Method
Difference in Residual tumor volume	<72h after surgery

Secondary Outcome Measures

Name	Time	Method
Survival	2 years after surgery
Complications, Clinical Performance, and Quality of Life	3 months after surgery

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Liege; 🇧🇪 Liege, Belgium

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands