Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Overview

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.

Full Title of Study: “Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2017

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Liver function assessed by hepatocyte fraction
    • Time Frame: 1 month after MRI
    • hepatocyte fraction obtained by T1 map sequence

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • National Research Foundation of Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeong Min Lee, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jeong Min Lee, MD, Principal Investigator, Seoul National University Hospital

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