Assessment of Safety and Feasibility of Exablate Type 2 for Blood-Brain Barrier Disruption (BBBD) With Microbubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Contrast intensity on MR imaging
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
详细描述
This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system with microbubble resonators. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be between 18-80 years old
- •Histologically confirmed glioblastoma
- •Planned for Carboplatin monotherapy
- •Be willing and able to provided written informed consent/asent
- •Tumor progression after first line chemo radiation
- •Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy
- •Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception
- •Able to communicate verbally
排除标准
- •Acute intracranial hemorrhage
- •Ferrous metallic implanted objects in the skull or brain
- •Prior toxicity with carboplatin chemotherapy
- •Women who are pregnant or breastfeeding
- •Cerebellar spinal cord or brain stem tumor
- •Known active Hepatitis B or Hepatitis C or HIV
- •Significant depression not adequately controlled
- •Has previously received anti-VEGF or anti-VEGF agents like Avastin
- •Cardiac disease or unstable hemodynamics
- •Severe hypertension
- •History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
- •Active drug or alcohol use disorder
- •Known sensitivity to gadolinium-based contrast agents
- •Known sensitivity or contraindications to ultrasound contrast agent or perflutren
- •Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices
- •Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication
- •Severely impaired renal function
- •Right to left or bi-directional cardiac shunt
- •Cranial or systemic infection requiring antibiotics
- •Known additional malignancy that is progression or require active treatment
研究组 & 干预措施
Exablate BBBD with carboplatin
Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.
干预措施: Carboplatin (Drug)
Exablate BBBD with carboplatin
Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.
干预措施: Exablate BBBD (Device)
结局指标
主要结局
Contrast intensity on MR imaging
时间窗: Immediately after Exablate BBBD procedure
BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging
Adverse events
时间窗: Through study completion, an average of 12 months
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
次要结局
未报告次要终点