Evaluation of Hepatic Fibrosis on Multiparametric MRI

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03085342
• Other study ID #: SNUH-2015-2993
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 2021
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hepatitis

Intervention

Diagnostic Test:
• Liver MRI
Multiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	GE Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatic fibrosis stage	F0-1 vs. F2-4 using multiparametric MRI	1 month after MRI
Secondary	presence of varix	presence of esophageal or gastric varices using multiparametric MRI	1 month after MRI
Secondary	comparison of portal flow measurement	comparison of portal flow measurement using DCE and precontrast flow measurement	1 month after MRI