Delta Radiomics for Liver Function Evaluation

Study Overview
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Brief Summary
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To evaluate the feasibility and efficacy of delta radiomics-derived index based on Gd-EOB-DTPA enhanced MRI as a new imaging biomarker for the quantitative assessment of liver function.

Detailed Description
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Delta radiomics is a novel concept proposed on the basis of radiomics. It can be used to evaluate the dynamic changes of imaging features in the time dimension, reflecting functional information of the tissue. In clinical practice, liver function can be evaluated by gadoxate enhanced MRI by measuring signal intensity. Most often, simple visual assessment is performed, but quantitative measurements are also done. Theoretically, liver function should also be possible to quantify by using delta radiomics, ie by subtracting MR imaging features obtained in the earlier phase from the latter phase.

Official Title
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Delta Radiomics Based on Gd-EOB-DTPA-enhanced MRI for Quantitative Evaluation of Liver Function

Conditions
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Chronic Liver Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years old, no gender limit. Patients with chronic liver disease and different degrees of liver damage (Child-Pugh A, B and C) and healthy controls. No history of liver-related surgery (except for cholecystectomy). No cardiopulmonary diseases or other diseases which may impair liver function. Agree to participate in the study and provide written informed consent. Exclusion Criteria: Alcoholic hepatitis, non-alcoholic fatty liver disease, or autoimmune hepatitis. Liver tumors or metastasis or other extraheptic tumor. Splenectomy or other cases where the spleen is absent. Chronic kidney disease, renal damage. Allergy to contrast agents or other conditions that cannot undergo Gd-EOB-DTPA enhanced MRI exam.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Healthy volunteers undergoing MRI exam, ICG test and blood biochemical tests | |
| Child-Pugh A Group<br>Composed of patients with liver function of Child-Pugh A grade undergoing MRI exam, ICG test and blood biochemical tests | |
| Child-Pugh B Group<br>Composed of patients with liver function of Child-Pugh B grade undergoing MRI exam,ICG test and blood biochemical tests | |
| Child-Pugh C Group<br>Composed of patients with liver function of Child-Pugh C grade undergoing MRI exam | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between delta radiomics parameter and ICG test in assessment of liver function | MRI and ICG tests performed within 3 days apart | within 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function | MRI and blood biochemical tests performed within 3 days apart | with 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver function, magnetic resonance imaging, radiomics, chronic liver disease, quantitative assement