Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging

Liver function is a key factor that can help predict the clinical outcome in patients with cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in several studies. There have been several approaches to measure liver function using gadoxetic acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced liver MRI is clinically used world widely, it would be valuable if we can measure liver function using hepatocyte fraction.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Drug: gadoxetic acid enhanced liver MRI; Drug: ICG R15

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

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 with chronic liver disease or liver cirrhosis
• clinically scheduled for gadoxetic acid enhanced liver MRI
• signed informed consent

Exclusion Criteria:

• under 18 years
• transarterial chemoembolization, radiation therapy for liver or bile duct within 2 weeks
• systemic chemotherapy within 6 weeks
• any contraindication for contrast enhanced MRI
• hepatic iron deposition at prior imaging
• bile duct obstruction

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: CLD and LC; Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group.

Drug: gadoxetic acid enhanced liver MRI; Gadoxetic acid enhanced liver MRI is performed and the standard dose of contrast media (0.025mmol/kg) is administered intravenously at a rate of 1mL/sec. Before and after contrast media injection, T1 map sequence is performed to calculate hepatocyte fraction. Routine MR sequences (T2WI, T1WI, dual-echo sequence, DWI, MR elastography) are performed according to clinical protocol in the institution.; Other Names: Primovist; Eovist; Drug: ICG R15; ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.; Other Names: Indocyanine green retention test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver function assessed by hepatocyte fraction	hepatocyte fraction obtained by T1 map sequence	1 month after MRI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver function assessed by ICG R15 test		3 days after MRI
Hepatocyte uptake rate	calculated hepatic uptake rate from T1 map sequence at MRI	1 month after MRI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver stiffness value (kPa)	liver stiffness from MR elastography	1 month after MRI
Spleen stiffness value (kPa)	spleen stiffness from MR elastography	1 month after MRI
adverse effect after contrast media administration		within an hour after contrast media administration
adverse effect after ICG administration		within an hour after ICG administration
T2* value (msec)	T2 star value obtained from Dixon sequence before and after contrast media administration	1 month after MRI
Bile duct excretion of contrast media on hepatobiliary phase	five point scale (1: no visualization, 5: opacification of 2nd branch~CBD)	1 month after MRI
ADC	apparent diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI
D	true diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI
D*	pseudodiffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI
f	perfusion fraction (%) from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 31, 2016
• First Submitted That Met QC Criteria: July 31, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 4, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: MRI; gadoxetic acid; T1 map
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: SNUH-2015-3375

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
• product manufactured in and exported from the U.S.: No