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Completed

NCT Number: NCT00943007

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

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.

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Liege, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stealth Station

Device

Neuronavigation based on preoperative MRI

Other names: cNN

PoleStar N20

Device

Intraoperative MRI guided surgery

Other names: iMRI

Primary outcomes

  1. Difference in Residual tumor volume

    Time frame: <72h after surgery

Secondary outcomes

  1. Complications, Clinical Performance, and Quality of Life

    Time frame: 3 months after surgery

  2. Survival

    Time frame: 2 years after surgery

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: RACING

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 21, 2009
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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