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

Glioblastoma Multiforme Clinical Trial

— RACING  

Official title:

Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943007
• Other study ID #: MEC 08-2-055
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: April 9, 2015
• Start date: February 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Device:
• Stealth Station
Neuronavigation based on preoperative MRI
• PoleStar N20
Intraoperative MRI guided surgery

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire de Liege	Liege
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Residual tumor volume		<72h after surgery	No
Secondary	Complications, Clinical Performance, and Quality of Life		3 months after surgery	Yes
Secondary	Survival		2 years after surgery	No