Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)

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.

Study Overview

• Status: Completed
• Conditions: Fibrosis; Cirrhosis
• Intervention / Treatment: Procedure: magnetic resonance imaging

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Magnetic resonance imaging; multiparametric MRI including perfusion, diffusion, MR fat quantification and MR elastography	Procedure: magnetic resonance imaging; multiparametric MRI as follows: diffusion weighted imaging using multiple b-values; Fat quantification sequence; perfusion MRI using ECCM agent; MR elastography------------------------------------; routine MRI using hepatocyte specific agent (optional in patients with focal liver lesion); Other Names: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis	in three years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Research Foundation of Korea

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2015
• Primary Completion (Actual): September 20, 2016
• Study Completion (Actual): August 28, 2020

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: MRI; cirrhosis; fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: SNUH-082-618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO