Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

gadoxetic acid MRI and ICG R15 test

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CLD and LC

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

Group Type EXPERIMENTAL

gadoxetic acid enhanced liver MRI

Intervention Type DRUG

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.

ICG R15

Intervention Type DRUG

ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.

Interventions

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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.

Intervention Type DRUG

ICG R15

ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.

Intervention Type DRUG

Other Intervention Names

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Primovist Eovist Indocyanine green retention test

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No