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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00943007
First received: July 20, 2009
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Glioblastoma Multiforme
 Device: Stealth Station
Device: PoleStar N20

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Difference in Residual tumor volume [ Time Frame: <72h after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications, Clinical Performance, and Quality of Life [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Neuronavigation
Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
 Device: Stealth Station
Neuronavigation based on preoperative MRI
Other Name: cNN
Experimental: Intraoperative MRI
Standard neuronavigation plus intraoperative MRI to correct for brain shift
 Device: PoleStar N20
Intraoperative MRI guided surgery
Other Name: iMRI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943007

Locations
Belgium
Centre Hospitalier Universitaire de Liege
Liege, Belgium
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00943007     History of Changes
Other Study ID Numbers: MEC 08-2-055
Study First Received: July 20, 2009
Last Updated: May 13, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on June 18, 2013