Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

Not Applicable

Completed

• Conditions: Fibrosis; Cirrhosis
• Interventions: Procedure: magnetic resonance imaging

• Registration Number: NCT02480972
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis.

Detailed Description

In patients with liver parenchymal disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included.

Referred patients undergo multiparametric MRI including perfusion, diffusion, elastography and fat quantification before surgery or biopsy.

The pathophysiologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis.

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-22
• Study Start: 2015-06-23
• Study First Posted: 2015-06-25
• Primary Completion: 2016-09-20
• Study Completion: 2020-08-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• patients who are scheduled to undergo liver resection for focal liver lesion
• patients who are scheduled to undergo liver resection or percutaneous biopsy for diffuse parenchymal disease
• liver donor candidate who are scheduled to undergo preoperative liver biopsy or liver resection
• AND patients/living donor candidates who sign informed consent

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Exclusion Criteria

Patients who have at least one of followings are excluded.

• Patients who are contraindication for MRI contrast enhanced MRI.
• Premenopausal female patients who are pregnant.
• Patients who are physically compromised to acquire liver MRI

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic resonance imaging	magnetic resonance imaging	multiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography

Primary Outcome Measures

Name	Time	Method
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis	in three years

Secondary Outcome Measures

Name	Time	Method
difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis	in three years
difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis	in three years
monitoring of transient dyspnea after contrast media injection	in three years

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of