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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional Neuronavigation

Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift

Group Type ACTIVE_COMPARATOR

Stealth Station

Intervention Type DEVICE

Neuronavigation based on preoperative MRI

Intraoperative MRI

Standard neuronavigation plus intraoperative MRI to correct for brain shift

Group Type EXPERIMENTAL

PoleStar N20

Intervention Type DEVICE

Intraoperative MRI guided surgery

Interventions

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Stealth Station

Neuronavigation based on preoperative MRI

Intervention Type DEVICE

PoleStar N20

Intraoperative MRI guided surgery

Intervention Type DEVICE

Other Intervention Names

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cNN iMRI

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No