Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854371
• Other study ID #: SNUH-2015-3375
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: May 2018

Study information

• Verified date: November 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver stiffness value (kPa)	liver stiffness from MR elastography	1 month after MRI
Other	Spleen stiffness value (kPa)	spleen stiffness from MR elastography	1 month after MRI
Other	adverse effect after contrast media administration		within an hour after contrast media administration
Other	adverse effect after ICG administration		within an hour after ICG administration
Other	T2* value (msec)	T2 star value obtained from Dixon sequence before and after contrast media administration	1 month after MRI
Other	Bile duct excretion of contrast media on hepatobiliary phase	five point scale (1: no visualization, 5: opacification of 2nd branch~CBD)	1 month after MRI
Other	ADC	apparent diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI
Other	D	true diffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI
Other	D*	pseudodiffusion coefficient from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI
Other	f	perfusion fraction (%) from DWI sequence using multiple b-values (0~800sec/mm2)	1 month after MRI
Primary	Liver function assessed by hepatocyte fraction	hepatocyte fraction obtained by T1 map sequence	1 month after MRI
Secondary	Liver function assessed by ICG R15 test		3 days after MRI
Secondary	Hepatocyte uptake rate	calculated hepatic uptake rate from T1 map sequence at MRI	1 month after MRI