Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

December 16, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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:

  1. diffusion weighted imaging using multiple b-values
  2. Fat quantification sequence
  3. perfusion MRI using ECCM agent

  4. MR elastography

    ------------------------------------

  5. 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
Time Frame: in three years
in three years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Research Foundation of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-082-618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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