Borderzone Sampling

Study Overview
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Brief Summary
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On regular (diagnostic) MRI images brain tumors can show contrast enhancement: uptake of an intravenously administered contrast agent can cause an enhancement pattern that is seen as a white area on a frequently used MRI protocol (T1 weighted imaging). High grade gliomas are a common brain tumor that share this enhancement pattern. The goal of surgery is to resect this contrast enhancing part without causing additional neurological damage. Intraoperative MRI (iMRI) is a helpful tool in achieving this goal, because it can provide updated images during resection and correct for deformations that occur in the brain during surgery. These deformations make preoperative images that are used for standard neuronavigation systems less reliable. However, due to manipulations during surgery, the contrast uptake during surgery may differ from contrast uptake in diagnostic MRI. This study aims to relate contrast enhancement on iMRI and tumor characteristics on tissue samples from the tumor. When the neurosurgeon considers the resection of the high grade glioma to be complete, an iMRI scan will be made, and tissue sampling will be performed on the borderzones of the tumor or tumor resection cavity respectively. This will provide insight in the relation between contrast enhancement on iMRI and the presence of tumor tissue. Such knowledge is important to improve effectiveness and safety of iMRI guided brain tumor resection.

Official Title
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Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor?

Conditions
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High Grade Glioma, Glioblastoma

Intervention / Treatment
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* Device: PoleStar N20 intraoperative MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: supratentorial brain tumor, on contrast enhanced MRI suspect for a high grade glioma indication for resection of the tumor age ≥ 18 years WHO Performance Scale ≤ 2 ASA class ≤ 3 good knowledge of the Dutch language informed consent Exclusion Criteria: recurrent tumor multiple tumor localizations prior radiotherapy on the skull prior chemotherapy

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PoleStar N20 intraoperative MRI<br>PoleStar N20 intraoperative MRI | Device: PoleStar N20 intraoperative MRI<br>* low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)<br>* Other names: manufactured by Odin Medical Technologies (Yokneam, Israel), incorporated in Medtronic Navigation (Louisville, CO; USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation between the shape and size of contrast enhancement on intraoperative MRI at the resection cavity border, and the presence of residual tumor tissue. |  | after surgery, and after 1 year for additional immunochemistry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation between possible contrast enhancement and contrast enhancing tissue volume on the last intraoperative MRI scan and the early diagnostic MRI scan |  | within 72 hours after surgery | 
| Postoperative clinical condition (WHO Performance Scale) |  | 1 week after surgery | 
| Survival (Kaplan Meier) |  | after 4 years |