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

This study is currently recruiting participants.
Verified October 2017 by Jung-Hwan Yoon, Seoul National University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447667
First Posted: October 6, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Jung-Hwan Yoon, Seoul National University Hospital:

Primary Outcome Measures:
  • 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


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 ]
    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 2018
Estimated Primary Completion Date: June 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 26, 2011
First Posted: October 6, 2011
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jung-Hwan Yoon, Seoul National University Hospital:
Hepatic fibrosis
Magnetic resonance elastography
Hepatocellular carcinoma
Recurrence

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