Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization and Its Impact on Overall Survival
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- Interobserver variability of the methods used for assessing tumor response to the treatment
研究概览
简要总结
The application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives:
To assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors To determinate interobserver variability of the methods.
详细描述
The patients with hepatocellular carcinoma in stage suitable for treatment by transarterial chemoembolization (TACE) with drug-eluting beads are included in the study. The investigators assess the response to the treatment by standard methods (RECIST, mRECIST) as well as by volumetric analysis. The size of tumor is evaluated on CT/MRI by two investigators prior to first TACE and then on all the check-ups (routinely every three months) until 31 December, 2019 or the patients' death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •diagnosis of HCC by a radiologist according to the European Association for the Study of the Liver (EASL) criteria or confirmed histologically
- •at least one TACE undergone at the University Hospital Brno
- •initial/ closing CT (Brillance 64, Philips, Netherlands; contrast enhancement 125 mL Iomeron 400, Bracco, Germany) or MRI study (Achieva, Philips, Netherlands, SENSE XL Torso coil 16 1.5T; contrast enhancement 15 mL Primovist, Bayer, Germany)
- •follow-up on or before December 31, 2019.
排除标准
- •when the inclusion criteria are not met.
结局指标
主要结局
Interobserver variability of the methods used for assessing tumor response to the treatment
时间窗: 4 years 11 months
RECIST, mRECIST, volumetric analysis
Predictive factors for overall survival and progression-free survival
时间窗: 4 years 11 months
RECIST, mRECIST, volumetric analysis
次要结局
- Response to the treatment, as assessed by volumetric analysis(4 years 11 months)
- Response to the treatment, as assessed by mRECIST(4 years 11 months)
- Time from observation until disease progression or death(4 years 11 months)
- Response to the treatment, as assessed by RECIST (v.1.1)(4 years 11 months)
- Time from observation until death due to any cause (or censoring)(4 years 11 months)
研究者
Monika Hajkova
Principal Investigator
Brno University Hospital