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

NCT01447667 | Completed DMC

• 1 other identifier: MRE
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatic Fibrosis; Hepatocellular Carcinoma

Keywords

Hepatic fibrosis; Magnetic resonance elastography; Hepatocellular carcinoma; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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

  within 2 years after RFA procedure

Secondary Outcomes (1)

• Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score

  2 years after RFA

Study Arms (1)

Magnetic resonance elastography

EXPERIMENTAL

Magnetic resonance elastography before radiofrequency ablation therapy will be performed.

Procedure: Magnetic resonance elastography

Interventions

Magnetic resonance elastography PROCEDURE

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

Magnetic resonance elastography

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Disease Attributes

Study Officials

• Jung-Hwan Yoon, M.D., Ph.D.

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor, M.D., Ph.D.

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: October 6, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)