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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma; Hepatic Fibrosis
• Interventions: Procedure: Magnetic resonance elastography

• Registration Number: NCT01447667
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-09-26
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-06
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic resonance elastography	Magnetic resonance elastography	Magnetic resonance elastography before radiofrequency ablation therapy will be performed.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of