Magnetic Resonance Elastography (MRE) as a Predictor of HCC Recurrence After Radiofrequency Ablation (RFA)

Study Overview
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Brief Summary
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The purpose of this study is to determine: The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis

Detailed Description
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To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC within 2 years after RFA treatment Local recurrence/intrahepatic distant recurrence Multivariable analysis including several related factors to find whether MRE score is an independent predictor of HCC recurrence even after adjusting other factors (etiology of liver disease, size of HCC, vessel invasion, HBsAg titer, etc.) To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis.

Official Title
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Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy

Conditions
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Hepatic Fibrosis, Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Magnetic resonance elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as single hypervascular hepatocellular carcinoma initially AJCC stage I HCC Child-Pugh class A Planning radiofrequency ablation for HCC Voluntary agreement for this study Exclusion Criteria: Decreased kidney function (GFR < 70 mL/min/kg) Contraindication to MRI (pacemaker, defibrillator) Contrast media hypersensitivity Other primary malignancy Acute viral hepatitis Prior history of liver transplantation Thrombosis in splenic vein or portal vein Patients who were enrolled to other clinical trials within 4 weeks Other severe chronic disease or psychiatric disease Pregnant or milk-feeding women Patients with coagulopathy, high risk of bleeding for the liver biopsy Patients who disagree to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Magnetic resonance elastography<br>Magnetic resonance elastography before radiofrequency ablation therapy will be performed. | Procedure: Magnetic resonance elastography<br>* Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who experienced HCC recurrence after RFA | To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment | within 2 years after RFA procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score | To find efficacy of each indicator (MRE, noninvasive serum markers such as APRI, P2/MS) compared to the gold-standard histology score in predicting hepatic fibrosis | 2 years after RFA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic fibrosis, Magnetic resonance elastography, Hepatocellular carcinoma, Recurrence