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

Seoul National University

Status: Completed

Conditions: Hepatic Fibrosis; Hepatocellular Carcinoma

Treatments: Procedure: Magnetic resonance elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT01447667

MRE

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Magnetic resonance elastography

Experimental group

Description:

Magnetic resonance elastography before radiofrequency ablation therapy will be performed.

Treatment:

Procedure: Magnetic resonance elastography