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

Intraoperative MRI is a technical tool to perform more effective and safer
brain surgery. Current default treatment (conventional neuronavigation (cNN))
uses preoperative brain scans. During surgery several changes occur that cause
"brain shift", a displacement of the brain. As a consequence, preoperative
brain scans become inaccurate during surgery. iMRI can acquire a new scan
during a surgical procedure to correct for this accuracy caused by brain shift.

Until now only prospective and retrospective cohort studies have been
performed, but no randomized study to assess effectiveness and safety of iMRI
compared to cNN. Less residual tumor volume is associated with prolonged
survival. The hypothesis is that use of iMRI leads to less residual tumor than
the use of cNN.

This study compares iMRI with cNN for the primary endpoint (percentage of
residual tumor volume) and the secondary endpoints (complications, clinical
functioning / quality of life, and survival).

A total of 54 patients with a brain tumor will be randomized in two treatment
groups: iMRI or cNN. Both groups will have a preoperative navigation scan made
within 72 hours before surgery. In both groups the neurosurgeon will operate
until he/she considers tumor resection to be maximal. In the cNN-group surgery
will be finished at that point. In the iMRI-group a new scan will be made after
administration of an intavenous contrast agent. If this shows contrast
enhancement that is interpreted by the neurosurgeon as being tumor tissue, this
will be resected if the neurosurgeon thinks this is justified. Then a new scan
will be made, and this "scan-resection-cycle" can be repeated until the
neurosurgeon considers the resection to be maximal. In the iMRI-group surgery
will be finished at that point. In both groups a new scan will be made within
48 hours after surgery. This will be used to measure postoperative tumor
volume. This will be compared to the preoperative tumor volume on the
preoperative navigation scan, to calculate the residual tumor volume.

Randomization in the iMRI or cNN group, after which treatment will be given as
desribed in the summary paragraph "Study Design". Before and after surgery the
patient will be requested to fill in some questionnaires to address quality of
life. This will be done at admission, at discharge, and 3 months after surgery.

Like explained and supported by literature references in the research protocol,
there are risks related to performing brain surgery. There are no indications
that this risk would be increased in the iMRI-group compared to the cNN-group
(default treatment). Surgery time in the iMRI-group will be approximately 90
minutes longer compared to the cNN-group. The only burden that patients have is
the questionnaires that they will be requested to fill in for three times.