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Quantitative MRI Imaging in Diffuse Liver Diseases (QMIDLD)

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ClinicalTrials.gov Identifier: NCT04626492
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
ShaoLin Li, Fifth Affiliated Hospital, Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment
Fibrosis and Cirrhosis of Liver Diagnostic Test: Quantitative MRI imaging

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
F0
Normal control group
 Diagnostic Test: Quantitative MRI imaging
Dynamic contrast enhanced magnetic 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
F1
Grade 1 of liver fibrosis
 Diagnostic Test: Quantitative MRI imaging
Dynamic contrast enhanced magnetic 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
F2
Grade 2 of liver fibrosis
 Diagnostic Test: Quantitative MRI imaging
Dynamic contrast enhanced magnetic 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
F3
Grade 3 of liver fibrosis
 Diagnostic Test: Quantitative MRI imaging
Dynamic contrast enhanced magnetic 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
F4
Hepatic cirrhosis
 Diagnostic Test: Quantitative MRI imaging
Dynamic contrast enhanced magnetic 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


Outcome Measures
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Primary Outcome Measures :
  1. Quantitative MRI imaging diagnose diffuse hepatic lesions [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Such as blood routine,liver function and liver enzyme,renal function, serous markers of liver fibrosis,blood lipid,indicators related to hepatitis virus infection,emergency biochemistry,etc.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626492


Contacts
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Contact: Yujuan Qin, Master 0086 756 2528321 qinyj5@mail.sysu.edu.cn
Contact: Shaolin Li, Director 0086 756 2528321 lishaolin1963@126.com

Locations
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China, Guangdong
52 Meihua East Road, New Xiangzhou Recruiting
Zhuhai, Guangdong, China, 519000
Contact: Yujuan Qin, Master    0086 756 2528321    qinyj5@mail.sysu.edu.cn   
Contact: Shaolin Li, Doctor    0086 756 2528321    lishaolin1963@126.com   
Principal Investigator: Shaolin Li, Doctor         
Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Shaolin Li, Director Radiology Department，the Fifth Affiliated Hospital of Sun Yat-sen University
More Information
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Publications:

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Responsible Party: ShaoLin Li, Director of Radiology Department, Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04626492    
Other Study ID Numbers: ZDWY.FSK.005
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShaoLin Li, Fifth Affiliated Hospital, Sun Yat-Sen University:
Magnetic resonance imaging
Fatty liver
Liver Steatosis
Steatohepatitis
 Liver Fibrosis
Hepatic Cirrhosis
Dynamic contrast enhanced magnetic resonance imaging
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Fibrosis
Pathologic Processes
Digestive System Diseases