Holmium-166 Retrospective Collection of Real-World Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 12
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.
详细描述
This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient with diagnosis of primary liver tumor or metastases in the liver.
- •Patients treated with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres from 15 July 2019 to 15 July
- •Patient is ≥ 18 years.
- •If required by national regulation, patient has understood and signed written informed consent to retrospective data collection.
排除标准
- •Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.
结局指标
主要结局
Overall survival (OS)
时间窗: 30 months
Time from SIRT procedure until death from any cause
Hepatic Progression Free Survival (HPFS)
时间窗: 30 months
Time from SIRT procedure until progression in the liver or death
Progression Free Survival (PFS)
时间窗: 30 months
Time from SIRT procedure until overall progression or death
Lung shunt prediction
时间窗: 1 month
Lung shunt prediction will be evaluated by comparing the predicted and actual lung shunt, either in terms of percentage or absorbed dose
Frequency and Severity of Adverse Events
时间窗: 30 months
The primary safety endpoint is defined in terms of incidence of adverse events CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 3, or any grade of a predefined list of events stemming from risk management of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres.
Tumor response in the liver
时间窗: 3 months
Response as per routine practice following the guidelines for corresponding tumor type
次要结局
- Administered activity(1 month)
- SIRT treatment approach(1 month)
- Liver volume treated(1 month)
- Tumor absorbed dose(1 month)
- Normal liver absorbed dose(1 month)
- Number of patients downstaged to liver resection or liver transplantation(30 months)
- The use of Q-SuiteTM in clinical practice(1 month)