Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors (RACING)
Primary Purpose
Glioblastoma Multiforme
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Stealth Station
PoleStar N20
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme
Eligibility 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
Sites / Locations
- Centre Hospitalier Universitaire de Liege
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Neuronavigation
Intraoperative MRI
Arm Description
Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
Standard neuronavigation plus intraoperative MRI to correct for brain shift
Outcomes
Primary Outcome Measures
Difference in Residual tumor volume
Secondary Outcome Measures
Complications, Clinical Performance, and Quality of Life
Survival
Full Information
NCT ID
NCT00943007
First Posted
July 20, 2009
Last Updated
April 9, 2015
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00943007
Brief Title
Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors
Acronym
RACING
Official Title
Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Neuronavigation
Arm Type
Active Comparator
Arm Description
Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
Arm Title
Intraoperative MRI
Arm Type
Experimental
Arm Description
Standard neuronavigation plus intraoperative MRI to correct for brain shift
Intervention Type
Device
Intervention Name(s)
Stealth Station
Other Intervention Name(s)
cNN
Intervention Description
Neuronavigation based on preoperative MRI
Intervention Type
Device
Intervention Name(s)
PoleStar N20
Other Intervention Name(s)
iMRI
Intervention Description
Intraoperative MRI guided surgery
Primary Outcome Measure Information:
Title
Difference in Residual tumor volume
Time Frame
<72h after surgery
Secondary Outcome Measure Information:
Title
Complications, Clinical Performance, and Quality of Life
Time Frame
3 months after surgery
Title
Survival
Time Frame
2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk van Santbrink, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier Martin, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Liege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Koo van Overbeeke, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Liege
City
Liege
Country
Belgium
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors
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