Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Study Overview
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Brief Summary
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Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be treated in time. These techniques combined could reach high diagnostic performance for detection of liver fibrosis, and could decrease the number of liver biopsies.

Detailed Description
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Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications. New imaging modalities such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM), diffusion kurtosis imaging (DKI), T1ρ relaxation time (T1ρ), T1 mapping of pre-contrast and hepatocyte phase using hepatocyte specific agent and susceptibility weighted imaging (SWI) allow non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. Patients with chronic liver disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. Referred patients undergo multiparametric MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI before surgery or biopsy. The pathologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis. To explore if combine these techniques could reach higher diagnostic performance for detection and grading of liver fibrosis. This project will provide a reliable and noninvasive method for the monitoring stage of liver fibrosis and therapeutic evaluation.

Official Title
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Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Conditions
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Liver Fibrosis, Cirrhosis

Intervention / Treatment
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* Diagnostic Test: Liver MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...) AND willingly able to complete all research procedures and follow the entire research process AND scheduled for liver resection or biopsy AND signed informed consent Exclusion Criteria: Any contraindication for contrast-enhanced MRI Pregnant or nursing women Any organ transplant history, and existing functional grafts (except corneal or fur grafts) Recent right upper quadrant patients with traumatic healed A serious history of illness or other evidence of a serious illness or suffering from any other disease Patients who have been enrolled in other interventional clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver MRI<br>Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI. | Diagnostic Test: Liver MRI<br>* Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI T1ρ T1mapping SWI and DWI | Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with histology | MRI within 3 months of liver biopsy or surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI T1ρ T1mapping SWI and DWI | Quantitative Diagnosis accuracy of MRI in the degree of fibrosis and advanced fibrosis compared with serological markers. | Blood Test taken on same day as MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Fibrosis, multiparametric magnetic resonance imaging