NCT02003339已完成不适用
Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Modifications of functional MRI parameters
研究概览
简要总结
For patients who are suffering from hepatocellular carcinoma and are treated with radioembolization, the purpose of this study is to analyse parameters of functional MRIs that are modified early and to detect parameters that vary significantly after treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma. Indication for radioembolization validated after pluridisciplinary committee meeting.
- •Isolated target on initial imagery (invasive hepatocellular carcinoma excluded)
- •WHO (World Health organization) Performance status: 0, 1 or 2
- •If cirrhosis, Child A score with total bilirubin less than 30 micromoles per liter
- •Creatinine clearance more or equal to 30 mL/min
- •Patient informed and consent signature obtained
排除标准
- •Invasive hepatocellular carcinoma without any isolated tumor
- •Disease needing 2 injections of Therasphere
- •Thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis
- •Previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization
- •No antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including Sorafenib
- •Associated disease which could prevent patient from receiving treatment
- •RMI contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy)
- •Patient already participating in an other therapeutic trial with an experimental drug
- •Pregnant or childbearing potential women or breastfeeding women
- •minors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) Unable to comply with trial medical follow-up for geographical, social or psychological reasons
- •Unable to sign an informed consent
研究组 & 干预措施
RMIs
Experimental
干预措施: Additional RMIs (Other)
结局指标
主要结局
Modifications of functional MRI parameters
时间窗: Before radioembolization and up to 6 months after radioembolization
次要结局
- Change of VEGF (vascular endothelial growth factor) release(From day 0 to 2 months)
- Correlation between functional MRIs parameters and tumoral response(Measured 6 months after radioembolization)
- Assessment of alternative morphological response criteria : EASL (European Association for study of the liver) and mRECIST (m response evaluation criteria in solid tumor) criteria. Link with RECIST response.(2 and 6 months)
研究者
研究点 (2)
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