Evaluation of Hepatic Fibrosis on Multiparametric MRI

Evaluation of Hepatic Fibrosis on Multiparametric MRI Including Portal Flow Measurement Using Dual-input Software: Preliminary Study

As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.

Study Overview

• Status: Unknown
• Conditions: Hepatitis; Cirrhosis
• Intervention / Treatment: Diagnostic test: Liver MRI

• Study Type: Interventional
• Enrollment (Actual): 49
• 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:

• chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
• Or transplant recipient for viral hepatitis and on anti-viral agent medication
• AND scheduled for liver resection, biopsy or transient elastography
• AND signed informed consent

Exclusion Criteria:

• younger than 18 years
• any contra-indication for contrast-enhanced MRI
• pregnant or nursing women
• biliary obstruction
• unable or unwilling to give informed consent

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
Experimental: Liver MRI; Liver MRI including noncontrast (precontrast) flow measurement, DCE, DWI using multiple b-values, MRE and MR fat quantification.	Diagnostic test: Liver MRI; Multiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hepatic fibrosis stage	F0-1 vs. F2-4 using multiparametric MRI	1 month after MRI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of varix	presence of esophageal or gastric varices using multiparametric MRI	1 month after MRI
comparison of portal flow measurement	comparison of portal flow measurement using DCE and precontrast flow measurement	1 month after MRI

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): September 25, 2019
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 18, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: MRI; liver; fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: SNUH-2015-2993

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No