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临床试验/NCT03176797
NCT03176797Unknown不适用

Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
MRI T1ρ T1mapping SWI and DWI

研究概览

简要总结

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be treated in time. These techniques combined could reach high diagnostic performance for detection of liver fibrosis, and could decrease the number of liver biopsies.

详细描述

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications. New imaging modalities such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM), diffusion kurtosis imaging (DKI), T1ρ relaxation time (T1ρ), T1 mapping of pre-contrast and hepatocyte phase using hepatocyte specific agent and susceptibility weighted imaging (SWI) allow non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. Patients with chronic liver disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. Referred patients undergo multiparametric MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI before surgery or biopsy. The pathologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis. To explore if combine these techniques could reach higher diagnostic performance for detection and grading of liver fibrosis. This project will provide a reliable and noninvasive method for the monitoring stage of liver fibrosis and therapeutic evaluation.

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

入选标准

  • chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
  • AND willingly able to complete all research procedures and follow the entire research process
  • AND scheduled for liver resection or biopsy
  • AND signed informed consent

排除标准

  • Any contraindication for contrast-enhanced MRI
  • Pregnant or nursing women
  • Any organ transplant history, and existing functional grafts (except corneal or fur grafts)
  • Recent right upper quadrant patients with traumatic healed
  • A serious history of illness or other evidence of a serious illness or suffering from any other disease
  • Patients who have been enrolled in other interventional clinical trials

研究组 & 干预措施

Liver MRI

Experimental

Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.

干预措施: Liver MRI (Diagnostic Test)

结局指标

主要结局

MRI T1ρ T1mapping SWI and DWI

时间窗: MRI within 3 months of liver biopsy or surgery

Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology

次要结局

  • MRI T1ρ T1mapping SWI and DWI(Blood Test taken on same day as MRI)

研究者

发起方
Zhujiang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Quan Xianyue

Professor

Zhujiang Hospital

研究点 (1)

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