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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00943007
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Maastricht University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Henk van Santbrink, MD, PhDDidier Martin, MD, PhDKoo van Overbeeke, MD, PhD
Principal Investigator Affiliation Maastricht University Medical CenterCentre Hospitalier Universitaire de LiegeMaastricht University Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Belgium, Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Arms & Interventions

Arms

Active Comparator: Conventional Neuronavigation

Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift

Experimental: Intraoperative MRI

Standard neuronavigation plus intraoperative MRI to correct for brain shift

Interventions

Device: - Stealth Station

Neuronavigation based on preoperative MRI

Device: - PoleStar N20

Intraoperative MRI guided surgery

Contact a Trial Team

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International Sites

Liege, Belgium

Status

Address

Centre Hospitalier Universitaire de Liege

Liege, ,

Maastricht University Medical Center, Maastricht, Netherlands

Status

Address

Maastricht University Medical Center

Maastricht, ,