DRKS00023339进行中（未招募）不适用
Performance and Safety of thermotherapy with nanoparticles (NanoTherm® Therapy System) as an adjuvant therapy to the Standard of Care treatment of patients with recurrent glioblastoma - The NanoTherm Registry
MagForce AG0 个研究点目标入组 5 人开始时间: 2020年10月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Male and female patients with recurrent glioblastoma (first or repeated recurrence)
- •Age 18-75 Years
- •Informed Consent in writing
- •Karnofsky Index = 60
- •Life expectancy > 6 months
- •Failed standard therapy (Stupp regiment, TTF)
- •Stable corticoid requirements = 2mg dexamethasone / d
- •Known Molecular differentiation (MGMT promoter methylation, IDH mutation status, 1p/19q deletion status)
- •Cardiopulmonary compliance (heat and lying flat in the field generator for approx. 60 minutes must be tolerated
- •Psychological resilience
排除标准
- •Patients older than 75years
- •Pregnant or breast-feeding women
- •> 3 multiple glioblastoma lesions
- •Speech or motor brain functions in/at resection area
- •Subependymal contrast enhancement in adjacent ventricles
- •Simultaneous therapy with immunomodulators
- •Metallic implants =40cm from the planned alternating field, e.g. dental seals, cervical spine implants, implant remnants from previous craniotomies, orthopedic trauma osteosynthesis material, port systems with a metallic base
- •Electronic implants, e.g. cardiac pacemakers or defibrillators, cochlear implants, DBS
- •Allergy/hypersensitivity to aminosilanes, iron oxide, acetic acid
- •Planned or current therapy with Optune®TTF
- •Uncontrolled claustrophobia
- •Pain caused by arthrosis and degenerative spinal disorders, which may not be controlled
研究者
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