Therapeutic Endovascular Embolization for Intracranial Meningioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in radiological tumor volume from baseline
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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.
研究组 & 干预措施
Endovascular embolization
干预措施: Endovascular embolization (Procedure)
结局指标
主要结局
Change in radiological tumor volume from baseline
时间窗: At 1 year, 3 year and 5 year
Volumetric segmentation of tumor volume
次要结局
- Change in neurological function(At 1 month)
- Number of participants with adverse events(30 days)
- 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)
- Change in generic health-related quality of life from baseline(At 1 months and 6 months)
- Change in domain-specific quality of life from baseline(At 1 months and 6 months)
- Number of participants with epileptic seizures(10 years)
- Change in disease-specific quality of life from baseline(At 1 months and 6 months)
- Loss of functional level from baseline(At 1 month and 6 months)
- Number of participants with moderate or severe procedure related complications within 30 days(30 days)