Embolization for Meningioma

St. Olavs Hospital30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meningioma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in radiological tumor volume from baseline

Volumetric segmentation of tumor volume

Time frame: At 1 year, 3 year and 5 year

Secondary Outcomes

Number of participants undergoing re-intervention for meningioma or treatment complications

Surgery or radiotherapy

Time frame: 10 years

Number of participants with epileptic seizures

Time frame: 10 years

Number of participants with moderate or severe procedure related complications within 30 days

Landriel Ibanez classification (grade 3 or 4 complications)

Time frame: 30 days

Change in generic health-related quality of life from baseline

EuroQol-5D 3L (EQ-5D 3L)

Time frame: 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

Time frame: 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

Time frame: At 1 months and 6 months

Change in neurological function

National Institutes of Health Stroke Scale (NIHSS)

Time frame: At 1 month

Number of participants with adverse events

Landriel Ibanez classification

Time frame: 30 days

Number of participants returning to work

Time frame: At 1 months and 6 months

Loss of functional level from baseline

\>10 points in Karnofsky performance status

Time frame: At 1 month and 6 months

Embolization for Meningioma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts