Quantitative MRI Imaging in Diffuse Liver Diseases (QMIDLD)

February 19, 2021 updated by: ShaoLin Li, Fifth Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • 52 Meihua East Road, New Xiangzhou
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shaolin Li, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Shaolin Li, Director, Radiology Department，the Fifth Affiliated Hospital of Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.FSK.005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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