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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00943007
First Posted: July 21, 2009
Last Update Posted: April 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
July 20, 2009
July 21, 2009
April 10, 2015
February 2010
June 2013   (Final data collection date for primary outcome measure)
Difference in Residual tumor volume [ Time Frame: <72h after surgery ]
Same as current
Complete list of historical versions of study NCT00943007 on ClinicalTrials.gov Archive Site
  • Complications, Clinical Performance, and Quality of Life [ Time Frame: 3 months after surgery ]
  • Survival [ Time Frame: 2 years after surgery ]
Same as current
Not Provided
Not Provided
 
Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors
Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Glioblastoma Multiforme
  • Device: Stealth Station
    Neuronavigation based on preoperative MRI
    Other Name: cNN
  • Device: PoleStar N20
    Intraoperative MRI guided surgery
    Other Name: iMRI
  • Active Comparator: Conventional Neuronavigation
    Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
    Intervention: Device: Stealth Station
  • Experimental: Intraoperative MRI
    Standard neuronavigation plus intraoperative MRI to correct for brain shift
    Intervention: Device: PoleStar N20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
 
NCT00943007
MEC 08-2-055
Yes
Not Provided
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Henk van Santbrink, MD, PhD Maastricht University Medical Center
Principal Investigator: Didier Martin, MD, PhD Centre Hospitalier Universitaire de Liege
Study Chair: Koo van Overbeeke, MD, PhD Maastricht University Medical Center
Maastricht University Medical Center
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP