Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy
18 Years
80 Years
Both
Hepatic Fibrosis, Hepatocellular Carcinoma
Trial Information
Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Number of patients who experienced HCC recurrence after RFA
Outcome Description:
To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment
Outcome Time Frame:
within 2 years after RFA procedure
Safety Issue:
No
Principal Investigator
Jung-Hwan Yoon, M.D., Ph.D.
Investigator Role:
Study Director
Investigator Affiliation:
Seoul National University Hospital
Authority:
South Korea: Institutional Review Board
Study ID:
MRE
NCT ID:
NCT01447667
Start Date:
October 2011
Completion Date:
December 2013
Related Keywords:
- Hepatic Fibrosis
- Hepatocellular Carcinoma
- Hepatic fibrosis
- Magnetic resonance elastography
- Hepatocellular carcinoma
- Recurrence
- Carcinoma
- Fibrosis
- Recurrence
- Liver Cirrhosis
- Carcinoma, Hepatocellular
Name | Location |
|---|
