Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PoleStar N20 | Device | — | UNRESOLVED |
| Stealth Station | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Neuronavigation
- description
- Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
- interventionNames
- Device: Stealth Station
- type
- EXPERIMENTAL
- label
- Intraoperative MRI
- description
- Standard neuronavigation plus intraoperative MRI to correct for brain shift
- interventionNames
- Device: PoleStar N20
Primary outcomes (1)
- measure
- Difference in Residual tumor volume
- timeFrame
- <72h after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available