Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Cirrhosis

Treatments: Drug: gadoxetic acid enhanced liver MRI; Drug: ICG R15

Study type: Interventional

Funder types: Other

Identifiers

NCT02854371

SNUH-2015-3375

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

CLD and LC

Experimental group

Description:

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

Treatment:

Drug: ICG R15

Drug: gadoxetic acid enhanced liver MRI