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Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

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ClinicalTrials.gov Identifier: NCT02854371
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: gadoxetic acid enhanced liver MRI Drug: ICG R15 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Intervention Model Description: gadoxetic acid MRI and ICG R15 test
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging
Actual Study Start Date : August 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 2018

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Arm Intervention/treatment
Experimental: CLD and LC
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

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

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




Primary Outcome Measures :
  1. Liver function assessed by hepatocyte fraction [ Time Frame: 1 month after MRI ]
    hepatocyte fraction obtained by T1 map sequence


Secondary Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854371


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
National Research Foundation of Korea
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital

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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02854371     History of Changes
Other Study ID Numbers: SNUH-2015-3375
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
gadoxetic acid
T1 map
MRI
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes
Liver Extracts
Hematinics