Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

August 1, 2020

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed

Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

November 10, 2020

Last Update Submit

February 19, 2021

Conditions

Fibrosis and Cirrhosis of Liver

Keywords

Magnetic resonance imagingFatty liverLiver SteatosisSteatohepatitisLiver FibrosisHepatic CirrhosisDynamic contrast enhanced magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

Quantitative MRI imaging diagnose diffuse hepatic lesions
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.
2 years