Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging
研究概览
简要总结
The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.
详细描述
The primary objective is to evaluate the safety and feasibility of BBB disruption using the Exablate Type 2.0 system in adult patients with glioblastoma (GBM) undergoing adjuvant TMZ chemotherapy, which occurs following maximal safe surgical resection and completion of the initial concurrent radiation-chemotherapy in accordance with the current standard of care
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is eligible for adjuvant TMZ treatment.
- •Men or women age between 18 and 80 years, inclusive.
- •Able and willing to give informed consent.
- •Grade IV glioma (GBM) confirmed Subjects
- •Karnofsky rating 70-
- •Able to communicate during the Exablate BBBD procedure.
- •Life expectancy of at least 3 months.
排除标准
- •Evidence of acute intracranial hemorrhage.
- •The subject presents with severe symptoms and signs of increased intracranial pressure
- •Patients with cerebellar or brainstem tumors.
- •Patients with positive HIV status
- •Patients with brain tumors containing 1p/19q chromosomal co-deletion
- •Patient receiving bevacizumab (Avastin) therapy
- •Patients undergoing other concurrent therapies
- •Cardiac disease or unstable hemodynamics
- •Severe hypertension
- •Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment
- •History of a bleeding disorder and/or coagulopathy
- •Known sensitivity to gadolinium-based contrast agents
- •Known sensitivity to ultrasound contrast agent
- •Severely impaired renal function
- •Subjects with significant liver dysfunction
研究组 & 干预措施
Focused Ultrasound (FUS) BBB Disruption
The Exablate Model 4000 Type 2.0 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing standard of care chemotherapy.
干预措施: Magnetic Resonance guided Focused ultrasound (MRgFUS) (Device)
结局指标
主要结局
Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging
时间窗: At the time of each ExAblate MRgFUS procedure]
The repeatability of BBB disruption will be evaluated at each of the 6 procedures and will be evaluated through assessment of post-procedure contrast-enhanced MR imaging.
Device and procedure related adverse events
时间窗: Throughout the study, approximately 12 months.
The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE
次要结局
未报告次要终点