NCT03276286已完成不适用
A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 14
- 主要终点
- Treatment-related Adverse Events (Safety)
研究概览
简要总结
This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •There is pathological evidence of GBM using World Health Organization (WHO) classification.
- •Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
- •Subject must have at least one measurable lesion per RANO.
- •Subject is at least 18 years of age.
- •Subject has a Karnofsky Performance Scale (KPS) ≥
- •Subject has life expectancy > 3 months.
- •Subject has adequate organ and marrow function; see note
- •Subject able to start treatment at least 28 days from tumor resection surgery.
- •Subject has provided signed informed consent.
排除标准
- •Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
- •Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- •Subject is currently being treated with Optune.
- •Subject is currently being treated with other investigational agents.
- •Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
- •Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
- •Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
- •Subject has a clinically significant electrolyte abnormality.
- •Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI. Subjects with programmable shunt are excluded from the study.
- •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 potentially confounding 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.
结局指标
主要结局
Treatment-related Adverse Events (Safety)
时间窗: Through study completion, average of 1 year
Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
次要结局
- Clinical Utility PFS(6 months)
- Clinical Utility OS(Through patient completion, expected average 8 months)
研究者
研究点 (14)
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