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

Seoul National University Hospital72 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hepatic Fibrosis Hepatocellular Carcinoma

Interventions

Magnetic resonance elastographyPROCEDURE

Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: within 2 years after RFA procedure

Secondary Outcomes

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

Time frame: 2 years after RFA

Data from ClinicalTrials.gov

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