Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

Study Overview
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Brief Summary
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Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition. In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow. Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.

Official Title
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Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI

Conditions
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Glioma

Intervention / Treatment
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* Procedure: intraoperative MRI-guided tumor resection
* Procedure: standard microsurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: known or suspected contrast-enhancing glioma (primary and recurrent) location of the tumor permits intended gross-total resection Exclusion Criteria: tumor location prohibits or questions gross-total resection contraindications to undergo MRI examinations

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: intraoperative MRI<br>tumor resection with intraoperative MRI-guidance | Procedure: intraoperative MRI-guided tumor resection<br>* tumor resection with the use of an intraoperative MRI<br>* Other names: PoleStar-N20 intraoperative MRI;|
| Active Comparator: conventional group<br>standard microsurgical tumor resection | Procedure: standard microsurgery<br>* microsurgical tumor resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Resection | Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Progression-free survival (radiological and/or clinical progression) at 6 months following surgery | 6 months | 
| Volumetric Assessment | Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI | 72 hours | 
| Neurological Deficit | Assessment of new postoperative deficits following tumor surgery | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative MRI, glioma surgery, extent of resection