Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Phase 4

Completed

• Conditions: Cirrhosis
• Interventions: Drug: gadoxetic acid enhanced liver MRI; Drug: ICG R15

• Registration Number: NCT02854371
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-07-31
• Study Start: 2016-08
• Study First Posted: 2016-08-03
• Primary Completion: 2017-02
• Study Completion: 2018-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-04
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLD and LC	gadoxetic acid enhanced liver MRI	Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group.
CLD and LC	ICG R15	Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group.

Primary Outcome Measures

Name	Time	Method
Liver function assessed by hepatocyte fraction	1 month after MRI	hepatocyte fraction obtained by T1 map sequence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of