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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01447667

Acronym

MRE

Enrollment

Registered

2011-10-06

Start date

2011-10-31

Completion date

2022-12-31

Last updated

2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Fibrosis, Hepatocellular Carcinoma

Keywords

Hepatic fibrosis, Magnetic resonance elastography, Hepatocellular carcinoma, Recurrence

Brief summary

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

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.

Interventions

PROCEDUREMagnetic resonance elastography

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score	2 years after RFA	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026