Meningioma
Conditions
Keywords
Brain neoplasms, Therapeutics
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
Interventions
PROCEDUREEndovascular embolization
Therapeutic endovascular embolization in general anesthesia
Sponsors
St. Olavs Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Historical controls from a regional brain tumor registry
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in radiological tumor volume from baseline | At 1 year, 3 year and 5 year | Volumetric segmentation of tumor volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Loss of functional level from baseline | At 1 month and 6 months | \>10 points in Karnofsky performance status |
| 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 | — |
| Number of participants with moderate or severe procedure related complications within 30 days | 30 days | Landriel Ibanez classification (grade 3 or 4 complications) |
| Change in generic health-related quality of life from baseline | At 1 months and 6 months | EuroQol-5D 3L (EQ-5D 3L) |
| 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 |
| Number of participants undergoing re-intervention for meningioma or treatment complications | 10 years | Surgery or radiotherapy |
Countries
Norway
Contacts
Primary ContactOle Solheim, PhD
Outcome results
None listed