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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT00943007

First received: July 20, 2009

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2009

Last Updated Date

May 13, 2013

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference in Residual tumor volume [ Time Frame: <72h after surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00943007 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Complications, Clinical Performance, and Quality of Life [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Glioblastoma Multiforme

Intervention ^ICMJE

Device: Stealth Station
Neuronavigation based on preoperative MRI

Other Name: cNN
Device: PoleStar N20
Intraoperative MRI guided surgery

Other Name: iMRI

Study Arm (s)

Active Comparator: Conventional Neuronavigation
Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift

Intervention: Device: Stealth Station
Experimental: Intraoperative MRI
Standard neuronavigation plus intraoperative MRI to correct for brain shift

Intervention: Device: PoleStar N20

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00943007

Other Study ID Numbers ^ICMJE

MEC 08-2-055

Has Data Monitoring Committee

Yes

Responsible Party

Maastricht University Medical Center

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Henk van Santbrink, MD, PhD	Maastricht University Medical Center
Principal Investigator:	Didier Martin, MD, PhD	Centre Hospitalier Universitaire de Liege
Study Chair:	Koo van Overbeeke, MD, PhD	Maastricht University Medical Center

Information Provided By

Maastricht University Medical Center

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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