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

April 9, 2015 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium
        • Centre Hospitalier Universitaire de Liège
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • cNN
Experimental: Intraoperative MRI
Standard neuronavigation plus intraoperative MRI to correct for brain shift
Device: PoleStar N20
Intraoperative MRI guided surgery
Other Names:
  • iMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Residual tumor volume
Time Frame: <72h after surgery
<72h after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications, Clinical Performance, and Quality of Life
Time Frame: 3 months after surgery
3 months after surgery
Survival
Time Frame: 2 years after surgery
2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Liège
  • Study Chair: Koo van Overbeeke, MD, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 20, 2009

First Submitted That Met QC Criteria

July 20, 2009

First Posted (Estimate)

July 21, 2009

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 08-2-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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