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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01447667
First received: September 26, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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

Condition Intervention
Hepatic Fibrosis
Hepatocellular Carcinoma
Procedure: Magnetic resonance elastography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Number of patients who experienced HCC recurrence after RFA [ Time Frame: within 2 years after RFA procedure ] [ Designated as safety issue: No ]
    To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment


Secondary Outcome Measures:
  • Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score [ Time Frame: 2 years after RFA ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 72
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447667

Contacts
Contact: Jung-Hwan Yoon, M.D., Ph.D +82-2072-2228 yoonjh@snu.ac.kr
Contact: Jeong-Hoon Lee, M.D. +82-2072-2228 pindra@empal.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jung-Hwan Yoon, M.D, Ph.D.    +82-2072-2228    yoonjh@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Jung-Hwan Yoon, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jung-Hwan Yoon, Clinical professor, M.D., Ph.D., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01447667     History of Changes
Other Study ID Numbers: MRE
Study First Received: September 26, 2011
Last Updated: December 2, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Hepatic fibrosis
Magnetic resonance elastography
Hepatocellular carcinoma
Recurrence

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Fibrosis
Liver Cirrhosis
Recurrence
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Disease Attributes
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014