Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Study Overview
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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.

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

Conditions
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Cirrhosis

Intervention / Treatment
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* Drug: gadoxetic acid enhanced liver MRI
* Drug: ICG R15


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: gadoxetic acid MRI and ICG R15 test
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLD and LC<br>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<br>* 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.<br>* Other names: Eovist;Drug: ICG R15<br>* ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.<br>* Other names: Indocyanine green retention test;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gadoxetic acid, T1 map, MRI