Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities
研究概览
简要总结
Stereotactic radiosurgery is a well established treatment option for arteriovenous malformations (AVMs). The potential complications related to radiosurgery are well documented and are predominately related to radiation effects to the surrounding brain parenchyma. These risks increase with larger lesions, requiring a concommitant reduction in the amount of radiation that can be delivered. This reduction in radiation dose decreases the efficacy of treatment. The broad, long-term objectives of this proposal are 1) to determine the role of fractionated stereotactic radiosurgery in the treatment of large (>10cc) AVMs; 2) to evaluate the complication rates related to fractionating these doses compared to conventional stereotactic treatment 3) to evaluate the success rate of treating large AVMs with this protocol.
详细描述
This research project will involve performing a preoperative MRI and angiogram on patients harboring an AVM to determine the feasibility of treating the lesion with gamma knife radiosurgery. Patient with lesions greater than 10 cc will be studied.
Each patient will have a Magnetic resonance angiography (MRA) with gadolinium and an angiogram immediately before each radiation treatment. If there is a contraindication for MRI examination (pacemaker or any other implanted ferromagnetic material), a CT angiogram will be obtained instead. Each treatment will be spaced at least 3 months apart. Follow-up MRIs or CT scans will be obtained at 6 month intervals. A follow-up angiogram will be obtained when there is radiographic evidence of complete occlusion based on the MRI images, or at 3 years after the procedure, whichever occurs first.
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
- •All patients age 18 or older
- •Inpatients and outpatients, referred for radiosurgical treatment of an arteriovenous malformation
- •Patients with lesions greater than 10 cc, who are currently symptomatic from the AVM (hemorrhage, seizure, or ischemia from steal phenomenon)
排除标准
- •Patients without symptoms related to AVM
研究组 & 干预措施
Fractionated stereotactic radiosurgery
The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
干预措施: Fractionated stereotactic radiosurgery (Procedure)
Fractionated stereotactic radiosurgery
The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
干预措施: Leskell gamma unit (Device)
结局指标
主要结局
Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities
时间窗: 10 years
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms
时间窗: 10 years
Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)
时间窗: 10 years
Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography
时间窗: 10 years
次要结局
- Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms(10 years)