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Completed

NCT Number: NCT02854371

Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

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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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gadoxetic acid enhanced liver MRI

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.

Other names: Primovist, Eovist

ICG R15

Drug

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

Other names: Indocyanine green retention test

Primary outcomes

  1. Liver function assessed by hepatocyte fraction

    Time frame: 1 month after MRI

    hepatocyte fraction obtained by T1 map sequence

Secondary outcomes

  1. Liver function assessed by ICG R15 test

    Time frame: 3 days after MRI

  2. Hepatocyte uptake rate

    Time frame: 1 month after MRI

    calculated hepatic uptake rate from T1 map sequence at MRI

Other outcomes

  1. Liver stiffness value (kPa)

    Time frame: 1 month after MRI

    liver stiffness from MR elastography

  2. Spleen stiffness value (kPa)

    Time frame: 1 month after MRI

    spleen stiffness from MR elastography

  3. adverse effect after contrast media administration

    Time frame: within an hour after contrast media administration

  4. adverse effect after ICG administration

    Time frame: within an hour after ICG administration

  5. T2* value (msec)

    Time frame: 1 month after MRI

    T2 star value obtained from Dixon sequence before and after contrast media administration

  6. Bile duct excretion of contrast media on hepatobiliary phase

    Time frame: 1 month after MRI

    five point scale (1: no visualization, 5: opacification of 2nd branch~CBD)

  7. ADC

    Time frame: 1 month after MRI

    apparent diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)

  8. D

    Time frame: 1 month after MRI

    true diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)

  9. D*

    Time frame: 1 month after MRI

    pseudodiffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)

  10. f

    Time frame: 1 month after MRI

    perfusion fraction (%) from DWI sequence using multiple b-values (0~800sec/mm2)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 3, 2016
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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