跳至主要内容
临床试验/NCT03142698
NCT03142698Unknown不适用

Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.

研究概览

简要总结

Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis

详细描述

Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma).

The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice.

Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis.

At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients.

Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
  • signature of written consent

排除标准

  • Contra-indications to MRI
  • Refusal of protocol
  • underage patients and protected adults

结局指标

主要结局

Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.

时间窗: at day 1

Correlation coefficient - for each quantitative MRI variable studied - with the histological score of hepatic steatosis.

次要结局

  • Measurement of intrahepatic iron(at day 1)
  • Measurement of intrahepatic fibrosis(at day 1)
  • Measurement of fat in different hepatic segments(at day 1)
  • Concordance between observers(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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