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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
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
July 20, 2009
Last Updated
April 9, 2015
Sponsor
Maastricht University Medical Center
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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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