Article
A prospective randomized trial on intraoperative MRI-guided vs. conventional microsurgical resection of gliomas
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Published: | April 28, 2011 |
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Objective: Our aim was to present a scientifically sound basis for the use of intraoperative MRI (iMRI) in glioma surgery.
Methods: We conducted a prospective randomized controlled trial comparing iMRI-guidance with conventional microsurgery in patients with contrast enhancing gliomas amenable to radiologically complete resection. Primary endpoint of this study was the rate of complete resections as determined by early postoperative MRI. In the iMRI group, a mobile ultra-low field iMRI device with a field strength of 0.15 T was used. All patients underwent high-field MRI within 7 days prior to and 72 hours following surgery. An independent radiologist who was blinded to the surgical treatment modality analyzed pre- and postoperative MRI data performing volumetric analyses. This study was approved by local authorities and was conducted in adherence to the Declaration of Helsinki and GCP-guidelines.
Results: 58 patients entered the study. Histological examination revealed metastasis in 8 patients, and 1 patient withdrew consent after randomization. Thus, 49 glioma patients could be analyzed. Patient characteristics (age, KPS score, preoperative tumor volume) were balanced between both groups. In the iMRI-group, intraoperative depiction of residual tumor led to additional resection in 8 patients (33.3%). Resections were complete in 23 out of 24 patients (95.8%) in the iMRI-group and in 17 out of 25 patients (68.0%) in the conventional group (P<0.05), which corresponded to significantly lower postoperative tumor volumes in the iMRI group (P<0.02). Overall morbidity was low and did not differ between groups (P=1.0).
Conclusions: We present scientific evidence that using iMRI-guidance in glioma surgery helps to achieve a higher rate of complete tumor resection compared to conventional microsurgery.