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

Hepatocellular Carcinoma Clinical Trial

— MRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447667
• Other study ID #: MRE
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: December 2022

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fibrosis
• Hepatic Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 2 years after RFA procedure
Secondary	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	2 years after RFA