Embolization for Meningioma

Официальное название

Therapeutic Endovascular Embolization for Intracranial Meningioma

Обзор

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

Вмешательства

• Процедура Endovascular embolization
  Therapeutic endovascular embolization in general anesthesia

Первичные конечные точки

• Change in radiological tumor volume from baseline [Срок оценки: At 1 year, 3 year and 5 year]

Вторичные конечные точки (10)

• Number of participants undergoing re-intervention for meningioma or treatment complications [Срок оценки: 10 years]
• Number of participants with epileptic seizures [Срок оценки: 10 years]
• Number of participants with moderate or severe procedure related complications within 30 days [Срок оценки: 30 days]
• Change in generic health-related quality of life from baseline [Срок оценки: At 1 months and 6 months]
• Change in disease-specific quality of life from baseline [Срок оценки: At 1 months and 6 months]
• Change in domain-specific quality of life from baseline [Срок оценки: At 1 months and 6 months]
• Change in neurological function [Срок оценки: At 1 month]
• Number of participants with adverse events [Срок оценки: 30 days]
• Number of participants returning to work [Срок оценки: At 1 months and 6 months]
• Loss of functional level from baseline [Срок оценки: At 1 month and 6 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• St Olavs Hospital — Trondheim

Идентификаторы

NCT: NCT05416567 · 392999

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗