Clinical trial NCT04626492: Quantitative MRI Imaging in Diffuse Liver Diseases
Official title: Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibrosis and Cirrhosis of Liver
Keywords: Magnetic resonance imaging
Fatty liver
Liver Steatosis
Steatohepatitis
Liver Fibrosis
Hepatic Cirrhosis
Dynamic contrast enhanced magnetic resonance imaging
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All suspected patients with diffuse liver diseases meet the inclusion criteria will include in this study. And patients who meet the criteria of the normal control group will include in this study

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.


Eligibility criteria: Inclusion Criteria:

Selection criteria for case group (F1-F4) (meet all the following 1-5 criteria can be selected or only meet the 6 criteria)

1. Fatty liver, liver fibrosis or cirrhosis confirmed by clinical, biochemical, imaging examination and liver biopsy;
2. no secondary portal hypertension and increase alpha feto protein(AFP);
3. no thrombus or plaque in the portal vein and abdominal aorta;
4. no history of psychotropic drug addiction;
5. MRI examination three days before liver puncture or liver transplantation;
6. 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):

1. no known acute or chronic liver disease (serologically negative);
2. no history of alcoholism, and normal liver function tests;
3. no signs of chronic liver disease in CT or MRI;
4. no CT or MRI manifestations of focal or diffuse liver disease in the liver;
5. abandoned donor liver

Exclusion Criteria:

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

Primary outcomes:
measure: Quantitative MRI imaging diagnose diffuse hepatic lesions
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: 52 Meihua East Road, New Xiangzhou
state: Guangdong
Study officials:
affiliation: Radiology Department，the Fifth Affiliated Hospital of Sun Yat-sen University
name: Shaolin Li, Director
role: PRINCIPAL_INVESTIGATOR
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