Embolization for Meningioma

Study Overview
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Brief Summary
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The natural course for meningioma suggests that a majority will grow over time. Treatment is usually indicated in growing or symptomatic meningiomas. Surgery is usually primary treatment, but there is a significant risk of adverse effects. Stereotactic radiotherapy is most often reserved to treat relapses after surgery, and except for surgery and radiotherapy there are no other established treatment methods. Endovascular embolization may be used in selected cases as a preoperative adjunct to reduce intraoperative bleeding. There is a need for more treatment options in patients with meningioma, both in uncomplicated, asymptomatic cases and in more complex cases. The aim of this study is to assess radiological and clinical results of therapeutic endovascular embolization for meningioma

Official Title
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Therapeutic Endovascular Embolization for Intracranial Meningioma

Conditions
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Meningioma

Intervention / Treatment
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* Procedure: Endovascular embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiological diagnose of typical intracranial meningioma (homogenous contrast enhancement or dural attachment) Indication for treatment due to growth, symptoms or both Tumor location suggestive of vascular supply via middle meningeal artery branches Age 18 years or older Karnofsky performance status of 90 or better (able to carry on normal activity and work) Exclusion Criteria: Informed consent not possible (e.g. language barriers, aphasia, cognitive impaired) Previously treated for meningioma Intraosseous growth Tumor related brain edema Neurofibromatosis type 2 Systemic cancer Epilepsy Progressive neurodegenerative disorder (eg. MS, Parkinsons disease) History of psychiatric disorder Unfit for participation for any other reason judged by the physician including patients Contraindications to MRI Allergic to contrast agents Relative contraindications to endovascular treatment judged from CT angiography (tortoise carotid arteries, carotid stenosis, calcified aortic arch, anatomical vascular variants/anomalies suggesting increased risk with endovascular treatment) DSA (Digital subtraction angiography) from carotid artery suggesting that significant vascular supply is from other vessels than the MMA.

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
Intervention Model: Single Group Assignment
Interventional Model Description: Historical controls from a regional brain tumor registry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular embolization<br> | Procedure: Endovascular embolization<br>* Therapeutic endovascular embolization in general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in radiological tumor volume from baseline | Volumetric segmentation of tumor volume | At 1 year, 3 year and 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants undergoing re-intervention for meningioma or treatment complications | Surgery or radiotherapy | 10 years | 
| Number of participants with epileptic seizures |  | 10 years | 
| Number of participants with moderate or severe procedure related complications within 30 days | Landriel Ibanez classification (grade 3 or 4 complications) | 30 days | 
| Change in generic health-related quality of life from baseline | EuroQol-5D 3L (EQ-5D 3L) | At 1 months and 6 months | 
| Change in disease-specific quality of life from baseline | The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire | At 1 months and 6 months | 
| Change in domain-specific quality of life from baseline | The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire | At 1 months and 6 months | 
| Change in neurological function | National Institutes of Health Stroke Scale (NIHSS) | At 1 month | 
| Number of participants with adverse events | Landriel Ibanez classification | 30 days | 
| Number of participants returning to work |  | At 1 months and 6 months | 
| Loss of functional level from baseline | >10 points in Karnofsky performance status | At 1 month and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain neoplasms, Therapeutics