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临床试验/NCT04626492
NCT04626492Unknown不适用

Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases

Fifth Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年8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
150
试验地点
1
主要终点
Quantitative MRI imaging diagnose diffuse hepatic lesions

研究概览

简要总结

As we all know, the early diagnosis and accurate staging of liver fibrosis are very important to reduce the incidence of liver cirrhosis and liver cancer. And the accurate evaluation of hepatic fibrosis is of great significance to the prediction of residual liver function after liver surgery. Therefore, clinicians pay more and more attention to the qualitative and quantitative diagnosis of hepatic fibrosis, liver cirrhosis and hepatic steatosis involved in diffuse liver diseases(such as fatty liver, viral hepatitis, autoimmune hepatitis ). And now, liver biopsy is commonly used as the gold standard for the evaluation of steatohepatitis and fibrosis. However, this test is invasive, has low patient acceptance. So more and more clinicians recommend non-invasive methods to qualitatively and quantitatively evaluate the liver steatosis, fibrosis and cirrhosis in diffuse liver diseases. At present, serum markers, ultrasonic elastography and magnetic resonance imaging have good accuracy in the non-invasive detection and evaluation of liver cirrhosis. However, serum markers are not liver-specific, and a single serum marker is not enough to accurately reflect the degree of liver fibrosis. Furthermore, whether the non-invasive liver fiber diagnostic model is suitable for patients with liver disease in China remains to be further verified. At present, transient elastography has been recommended for the non-invasive staging of hepatic fibrosis by the clinical practice guidelines of the European Association for liver Research and the Asia-Pacific Association for liver Research. But as serum markers, it still has low sensitivity and specificity in the diagnosis of early hepatic fibrosis, and is highly operationally dependent. With the development of MRI technology, some MRI quantitative techniques, such as T1mapping, T2mapping,Intravoxel incoherent motion diffusion-weighted magnetic resonance imaging(IVIM-DWI), dynamic contrast enhanced magnetic resonance imaging(DCE-MRI) can be used to qualitatively and quantitatively diagnosis of liver fat, hepatic fibrosis and cirrhosis. And iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence(IDEALIQ) usually used to evaluate liver fat. The existing research results showed that MRI quantitative techniques has a high value in quantitative diagnosis of advanced hepatic fibrosis and cirrhosis. But it still has some limitations in quantitative diagnosis of early liver fibrosis. And what's more,some of the research results still can not reach a consensus. Therefore, based on the multi-parameter potential of MRI and the characteristics of metabolic evaluation. This study will adjust some of the parameters of MRI quantitative techniques, and through large sample datas, combined with a variety of quantitative techniques to explore the application value of MRI quantitative techniques in the quantitative diagnosis of liver diffuse lesions, especially in the early stage of liver fibrosis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Selection criteria for case group (F1-F4) (meet all the following 1-5 criteria can be selected or only meet the 6 criteria)
  • Fatty liver, liver fibrosis or cirrhosis confirmed by clinical, biochemical, imaging examination and liver biopsy;
  • no secondary portal hypertension and increase alpha feto protein(AFP);
  • no thrombus or plaque in the portal vein and abdominal aorta;
  • no history of psychotropic drug addiction;
  • MRI examination three days before liver puncture or liver transplantation;
  • isolated liver of patients undergoing liver transplantation.
  • The selection criteria of the normal control group (F0) (meet all the following 1-4 criteria can be selected or only meet the 5 criteria):
  • no known acute or chronic liver disease (serologically negative);
  • no history of alcoholism, and normal liver function tests;
  • no signs of chronic liver disease in CT or MRI;
  • no CT or MRI manifestations of focal or diffuse liver disease in the liver;
  • abandoned donor liver

排除标准

  • contraindications for MRI or patients' inability to cooperate with MRI;
  • allergy to contrast media and poor image quality can not meet the needs of clinical diagnosis;
  • less than 18 years of age, poor quality of liver biopsy;
  • renal insufficiency (eGFP < 60ml/min/1.73mm2);
  • with severe heart, brain, lung and blood system diseases.
  • liver complicated with fulminant liver failure and gastrointestinal bleeding.

结局指标

主要结局

Quantitative MRI imaging diagnose diffuse hepatic lesions

时间窗: 2 years

Quantitative MRI imaging(such as dynamic contrast enhanced magnetic, intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging resonance imaging, Intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging, Iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence) used to quantitative diagnosis of fatty liver hepatitis, liver fibrosis, cirrhosis, etc.

次要结局

未报告次要终点

研究者

发起方
Fifth Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ShaoLin Li

Director of Radiology Department

Fifth Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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