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Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Primary Purpose

Cirrhosis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gadoxetic acid enhanced liver MRI
ICG R15
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring gadoxetic acid, T1 map, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLD and LC

Arm Description

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

Outcomes

Primary Outcome Measures

Liver function assessed by hepatocyte fraction
hepatocyte fraction obtained by T1 map sequence

Secondary Outcome Measures

Liver function assessed by ICG R15 test
Hepatocyte uptake rate
calculated hepatic uptake rate from T1 map sequence at MRI

Full Information

First Posted
July 31, 2016
Last Updated
November 4, 2018
Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02854371
Brief Title
Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI
Official Title
Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
gadoxetic acid, T1 map, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
gadoxetic acid MRI and ICG R15 test
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLD and LC
Arm Type
Experimental
Arm Description
Patients with underlying chronic liver disease. Gadoxetic acid enhanced liver MRI and ICG R15 are performed in this group.
Intervention Type
Drug
Intervention Name(s)
gadoxetic acid enhanced liver MRI
Other Intervention Name(s)
Primovist, Eovist
Intervention Description
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
Intervention Name(s)
ICG R15
Other Intervention Name(s)
Indocyanine green retention test
Intervention Description
ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.
Primary Outcome Measure Information:
Title
Liver function assessed by hepatocyte fraction
Description
hepatocyte fraction obtained by T1 map sequence
Time Frame
1 month after MRI
Secondary Outcome Measure Information:
Title
Liver function assessed by ICG R15 test
Time Frame
3 days after MRI
Title
Hepatocyte uptake rate
Description
calculated hepatic uptake rate from T1 map sequence at MRI
Time Frame
1 month after MRI
Other Pre-specified Outcome Measures:
Title
Liver stiffness value (kPa)
Description
liver stiffness from MR elastography
Time Frame
1 month after MRI
Title
Spleen stiffness value (kPa)
Description
spleen stiffness from MR elastography
Time Frame
1 month after MRI
Title
adverse effect after contrast media administration
Time Frame
within an hour after contrast media administration
Title
adverse effect after ICG administration
Time Frame
within an hour after ICG administration
Title
T2* value (msec)
Description
T2 star value obtained from Dixon sequence before and after contrast media administration
Time Frame
1 month after MRI
Title
Bile duct excretion of contrast media on hepatobiliary phase
Description
five point scale (1: no visualization, 5: opacification of 2nd branch~CBD)
Time Frame
1 month after MRI
Title
ADC
Description
apparent diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)
Time Frame
1 month after MRI
Title
D
Description
true diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)
Time Frame
1 month after MRI
Title
D*
Description
pseudodiffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)
Time Frame
1 month after MRI
Title
f
Description
perfusion fraction (%) from DWI sequence using multiple b-values (0~800sec/mm2)
Time Frame
1 month after MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

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