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临床试验/NCT03995823
NCT03995823已完成不适用

MRI Evaluation of Nidus Occlusion After Gamma Knife Radiosurgery of Cerebral Arteriovenous Malformations - A Prospective Preliminary Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Post radiosurgical AVM nidus obliteration on DSA

研究概览

简要总结

Cerebral arteriovenous malformations (AVMs) are abnormal vessels, connecting cerebral arteries and veins. They form a bundle which is called nidus. Rupture of an AVM leads to intracranial hemorrhage often causing neurological impairment or even death. As treatment can be associated with high rates of morbidity and mortality, AVMs still remain a considerable challenge for neurosurgeons. For smaller AVMs, a well-established treatment option is non-invasive Gamma Knife radiosurgery (GKRS). GKRS uses radiation to obliterate the AVM nidus hence, eliminating the risk of hemorrhage. However, after Gamma Knife radiosurgery, occlusion of the AVM nidus takes about two years. To evaluate treatment success after GKRS, invasive digital subtraction angiography (DSA) is still the gold standard. For this procedure, patients have to undergo puncture of the femoral artery for application of a contrast media to receive adequate imaging of the cerebral arteries. In recent literature it has been discussed whether sufficient evaluation of treatment is possible with non-invasive magnetic resonance imaging (MRI). At present, it is unclear whether this method could replace the current invasive gold standard for treatment evaluation. To investigate on this issue, a few studies have compared the two methods however, only retrospective data exist. Thus, the investigators are conducting this prospective study including 50 patients with cerebral AVMs treated with GRKS to evaluate the sensitivity for nidus obliteration of MRI using DSA as a reference.

详细描述

Background

Cerebral arteriovenous malformations consist of tangled blood vessels forming a so-called nidus which connects arteries to veins without the interposition of a capillary bed. Due to subsequent structural changes of draining veins within the nidus, patients are at risk of cerebral hemorrhage. Bleedings of AVMs are associated with high morbidity and mortality. Therefore, once a cerebral AVM is diagnosed, preventive treatment usually is aimed for. If hemorrhage already occurred treatment is necessary because of a high chance of re-bleeding. Cerebral AVMs are likely to cause neurological symptoms such as seizures and focal deficits without bleeding. These symptoms are usually due to the AVM's mass effect however, they have also been discussed to be caused by a vascular steal syndrome.

Etiology

The etiology of cerebral AVMs is not known. Aside from the possibility of a multifactorial cause it seems that genetic mutation and angiogenetic stimulation could play a role in their development. It is also discussed whether AVMs develop in utero or through an angiopathic reaction following ischemia or hemorrhage.

Epidemiology

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must undergo or have undergone Gamma Knife radiosurgery due to cerebral AVM
  • For inclusion patients must have their two-year follow-up MRI exam within the duration of study
  • All patients have to sign a form for participation in the study after purpose and process of the study has been explained to them.
  • For patients younger than 18 years, a parent or legal guardian has to sign a form for participation after being informed about purpose and process of the study have been explained to them.

排除标准

  • Patients who do not give informed consent to participate
  • Patients younger than 16 years

结局指标

主要结局

Post radiosurgical AVM nidus obliteration on DSA

时间窗: DSA will be performed within 2 months after MRI/MRA

Reference method for evaluation of sensitivity and specificity of MRI/MRA

Post radiosurgical AVM nidus obliteration on MRI

时间窗: The MRI examination will be performed 2 years after Gamma Knife treatment.

Sensitivity and specificity of MRI/MRA evaluated by catheter angiography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josa M Frischer, MD, PhD

Assoc.Prof.Priv.Doz.Dr.PhD

Medical University of Vienna

研究点 (1)

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