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临床试验/NCT02854371
NCT02854371已完成4 期

Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
54
试验地点
1
主要终点
Liver function assessed by hepatocyte fraction

研究概览

简要总结

Liver function is a key factor that can help predict the clinical outcome in patients with cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in several studies. There have been several approaches to measure liver function using gadoxetic acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced liver MRI is clinically used world widely, it would be valuable if we can measure liver function using hepatocyte fraction.

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

入选标准

  • patients with chronic liver disease or liver cirrhosis
  • clinically scheduled for gadoxetic acid enhanced liver MRI
  • signed informed consent

排除标准

  • under 18 years
  • transarterial chemoembolization, radiation therapy for liver or bile duct within 2 weeks
  • systemic chemotherapy within 6 weeks
  • any contraindication for contrast enhanced MRI
  • hepatic iron deposition at prior imaging
  • bile duct obstruction

研究组 & 干预措施

CLD and LC

Experimental

Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group.

干预措施: gadoxetic acid enhanced liver MRI (Drug)

CLD and LC

Experimental

Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group.

干预措施: ICG R15 (Drug)

结局指标

主要结局

Liver function assessed by hepatocyte fraction

时间窗: 1 month after MRI

hepatocyte fraction obtained by T1 map sequence

次要结局

  • Hepatocyte uptake rate(1 month after MRI)
  • Liver function assessed by ICG R15 test(3 days after MRI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Min Lee

Professor

Seoul National University Hospital

研究点 (1)

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