Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Guerbet
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
研究概览
简要总结
The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.
详细描述
One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and:
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Time to Progression (TTP)
Three DCE-MRI examinations were done during the study:
- at the enrolment and initiation of the sorafenib treatment
- one week after initiation of the sorafenib treatment
- two weeks after initiation of the sorafenib treatment
DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gadoterate meglumine
there is one single arm of patients (no comparative arm)
干预措施: Gadoterate meglumine (Drug)
结局指标
主要结局
Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
时间窗: 3 months
To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib. * Ktrans: volume transfer constant between blood plasma and extravascular extracellular space * AUC : area under the curve of tissue gadolinium concentration-time * ve: fractional volume of extravascular extracellular space * kep: rate constant between extravascular extracellular space and blood plasma (=Ktrans/ve) * T1: longitudinal relaxation time * Wash-in: slope of the early enhancement curve * Washout: slope of the late enhancement curve The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib). The correlation analyses were done using Pearson or Spearman correlation coefficient.
次要结局
- Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival(1 year)
- Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival(1 year)
- Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression(1 year)