NCT02507102已完成不适用
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Tumor Response
研究概览
简要总结
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.
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
- •Subject has histologically confirmed diagnosis of GBM.
- •Subject has failed or intolerant to radiotherapy.
- •Subjects has failed or intolerant to temozolomide therapy.
- •Subject has progressive disease with at least one measureable lesion on MRI or CT.
- •Subject is at least 18 years of age.
- •Subject has a KPS ≥
- •Subject has adequate organ and marrow function.
- •Subject has provided signed informed consent.
排除标准
- •Subject has life expectancy less than eight weeks
- •Subject has received other investigational therapy within the last 28 days.
- •Subject has received surgery within the last two weeks or not fully from prior surgery.
- •Subject has a clinically significant electrolyte abnormality.
- •Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
- •Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
- •Subject is known to be HIV positive.
- •Subject is pregnant, nursing or intends to become pregnant during the study period.
- •Subject is participating in other investigational research.
- •Subject has any condition that at the discretion of the investigator would preclude participation in the study.
- •Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
研究组 & 干预措施
Investigational Voyager Therapy
Experimental
Investigational treatment with Voyager Therapy
干预措施: Voyager (Device)
结局指标
主要结局
Tumor Response
时间窗: 2 months
Tumor imaging response (RANO) at two months of therapy.
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
时间窗: 6 months
次要结局
- Progression free survival(6 months)
- Overall survival at six months compared with historical response(6 months)
研究者
研究点 (2)
Loading locations...
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