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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Device: Stealth Station
* Device: PoleStar N20


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Neuronavigation<br>Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift | Device: Stealth Station<br>* Neuronavigation based on preoperative MRI<br>* Other names: cNN;|
| Experimental: Intraoperative MRI<br>Standard neuronavigation plus intraoperative MRI to correct for brain shift | Device: PoleStar N20<br>* Intraoperative MRI guided surgery<br>* Other names: iMRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Residual tumor volume |  | <72h after surgery | 

Secondary Outcome Measures

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