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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00943007
Acronym
RACING
Enrollment
14
Registered
2009-07-21
Start date
2010-02-28
Completion date
2013-12-31
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

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.

Interventions

DEVICEPoleStar N20

Intraoperative MRI guided surgery

DEVICEStealth Station

Neuronavigation based on preoperative MRI

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Difference in Residual tumor volume<72h after surgery

Secondary

MeasureTime frame
Complications, Clinical Performance, and Quality of Life3 months after surgery
Survival2 years after surgery

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026