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

Primary Purpose

Hepatic Fibrosis, Hepatocellular Carcinoma

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnetic resonance elastography
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatic Fibrosis focused on measuring Hepatic fibrosis, Magnetic resonance elastography, Hepatocellular carcinoma, Recurrence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic resonance elastography

Arm Description

Magnetic resonance elastography before radiofrequency ablation therapy will be performed.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2011
Last Updated
May 3, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01447667
Brief Title
Magnetic Resonance Elastography (MRE) as a Predictor of HCC Recurrence After Radiofrequency Ablation (RFA)
Acronym
MRE
Official Title
Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2011 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Fibrosis, Hepatocellular Carcinoma
Keywords
Hepatic fibrosis, Magnetic resonance elastography, Hepatocellular carcinoma, Recurrence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic resonance elastography
Arm Type
Experimental
Arm Description
Magnetic resonance elastography before radiofrequency ablation therapy will be performed.
Intervention Type
Procedure
Intervention Name(s)
Magnetic resonance elastography
Intervention Description
Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue
Primary Outcome Measure Information:
Title
Number of patients who experienced HCC recurrence after RFA
Description
To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment
Time Frame
within 2 years after RFA procedure
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score
Description
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
Time Frame
2 years after RFA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hwan Yoon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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