Embolization for Meningioma
- Conditions
- Meningioma
- Interventions
- Procedure: Endovascular embolization
- Registration Number
- NCT05416567
- Lead Sponsor
- St. Olavs Hospital
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endovascular embolization Endovascular embolization -
- Primary Outcome Measures
Name Time Method Change in radiological tumor volume from baseline At 1 year, 3 year and 5 year Volumetric segmentation of tumor volume
- Secondary Outcome Measures
Name Time Method Change in neurological function At 1 month National Institutes of Health Stroke Scale (NIHSS)
Number of participants with adverse events 30 days Landriel Ibanez classification
Number of participants returning to work At 1 months and 6 months Number of participants undergoing re-intervention for meningioma or treatment complications 10 years Surgery or radiotherapy
Change in generic health-related quality of life from baseline At 1 months and 6 months EuroQol-5D 3L (EQ-5D 3L)
Change in domain-specific quality of life from baseline At 1 months and 6 months The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire
Number of participants with epileptic seizures 10 years Change in disease-specific quality of life from baseline At 1 months and 6 months The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
Loss of functional level from baseline At 1 month and 6 months \>10 points in Karnofsky performance status
Number of participants with moderate or severe procedure related complications within 30 days 30 days Landriel Ibanez classification (grade 3 or 4 complications)
Trial Locations
- Locations (1)
St Olavs Hospital
🇳🇴Trondheim, Norway