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

NCT ID: NCT01447667

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Hepatic Fibrosis Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Magnetic resonance elastography

Magnetic resonance elastography before radiofrequency ablation therapy will be performed.

Group Type EXPERIMENTAL

Magnetic resonance elastography

Intervention Type PROCEDURE

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

Interventions

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Magnetic resonance elastography

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Hwan Yoon

Clinical professor, M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Hwan Yoon, M.D., Ph.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MRE

Identifier Type: -

Identifier Source: org_study_id