MRI Evaluation of Nidus Occlusion After Gamma Knife Radiosurgery of Cerebral Arteriovenous Malformations - A Prospective Preliminary Study
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
- 否
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
Josa M Frischer, MD, PhD
Assoc.Prof.Priv.Doz.Dr.PhD
Medical University of Vienna
