Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

Cirrhosis Clinical Trial

Official title:

Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480972
• Other study ID #: SNUH-082-618
• Status: Completed
• Phase: N/A
• Start date: June 23, 2015
• Est. completion date: August 28, 2020

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 28, 2020
• Est. primary completion date: September 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis		in three years
Secondary	difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis		in three years
Secondary	difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis		in three years
Secondary	monitoring of transient dyspnea after contrast media injection		in three years