Embolization for Meningioma (e-men)

St. Olavs Hospital

Status: Enrolling

Conditions: Meningioma

Treatments: Procedure: Endovascular embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT05416567

392999

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Endovascular embolization

Experimental group

Treatment:

Procedure: Endovascular embolization