DRKS00005584已完成4 期
Maintenance therapy with Everolimus in patients with tuberous sclerosis successfully treated for subependymal giant cell astrocytoma - EMINENTS (Everolimus MaINtENance Therapy in SEGA)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 0 Months 至 20 Years（—）
- 性别
- All
入选标准
- •Diagnosis of Tuberous sclerosis and supependymal giant astrocytoma.
- •At least 12 months everolimus treatment resulting in reduction (more than 30% decrease of tumor volume) or stabilization (less than 20% increase in tumor volume) of SEGA volume.
- •No signs of increased intracranial pressure/no hydrocephalus in MRI
- •Signed informed consent to the trial.
排除标准
- •No diagnosis of TSC
- •Age > 20 years
- •Progression (more than 20% increase of tumor volume) of SEGA volume during everolimus treatment in standard dose.
- •Signs of increased intracranial pressure/hydrocephalus in MRI during everolimus treatment in standard dose.
- •No signed informed consent to the trial.
研究者
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