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

November 21, 2023 updated by: Jung-Hwan Yoon, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic resonance elastography
Magnetic resonance elastography before radiofrequency ablation therapy will be performed.
Procedure: Magnetic resonance elastography
Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who experienced HCC recurrence after RFA
Time Frame: 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
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
Time Frame: 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
2 years after RFA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jung-Hwan Yoon, M.D., Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimated)

October 6, 2011

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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