RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 8
- 主要终点
- Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting
研究概览
简要总结
This study is a non-interventional, observational, prospective, and global participant data registry. The study will collect effectiveness and safety data from approximately 1000 participants with liver cancers treated with TheraSphere® in a real-life setting from multiple centers globally. The absorbed dose to tumor and normal tissue will be calculated using the Simplicit90Y™ software in the subgroup of hepatocellular carcinoma (HCC) participants.
详细描述
This study is a non-interventional, observational, prospective and global participant data registry.
Approximately 1000 participants with liver cancers who are treated with TheraSphere® will be enrolled.
Data regarding participant and treatment characteristics (TheraSphere® and other anti-cancer treatments) will be collected within a 12-month period post TheraSphere® administration to:
- Assess treatment effectiveness and safety in a real-life administration setting
- Identify prognostic and predictive factors for liver cancer participants receiving TheraSphere® treatment
Data for dosimetry determination will be collected on approximately 300 HCC participants to assess:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Participant is ≥ 18 years of age
- •Participant has confirmed liver cancer
- •Participant is able to provide informed consent according to local requirements/law
- •Participant has a life expectancy of ≥ 3 months
- •Participant is scheduled to receive TheraSphere® treatment
排除标准
- •Participant who has previously received Y90 microspheres
- •Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment
结局指标
主要结局
Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting
时间窗: 12 months follow up post last TheraSphere® treatment
Tumor response to TheraSphere® treatment will be assessed using Modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 depending on tumor type.
次要结局
- Adverse events of interest(6 months follow up post last TheraSphere® treatment)
- Serious adverse events(6 months follow up post last TheraSphere® treatment)
- TheraSphere® Dosimetry in the subgroup of HCC participants(From up to 30 days until the date of TheraSphere® Treatment and Baseline)