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

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Glioblastoma Multiforme

Treatments

Device: Stealth Station
Device: PoleStar N20

Study type

Interventional

Funder types

Other

Identifiers

NCT00943007
MEC 08-2-055

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

14 participants in 2 patient groups

Conventional Neuronavigation
Active Comparator group
Description:
Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
Treatment:
Device: Stealth Station
Intraoperative MRI
Experimental group
Description:
Standard neuronavigation plus intraoperative MRI to correct for brain shift
Treatment:
Device: PoleStar N20

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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