Cirrhosis
Conditions
Keywords
gadoxetic acid, T1 map, MRI
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.
Interventions
DRUGgadoxetic 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.
DRUGICG R15
ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.
Sponsors
National Research Foundation of Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
gadoxetic acid MRI and ICG R15 test
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver function assessed by hepatocyte fraction | 1 month after MRI | hepatocyte fraction obtained by T1 map sequence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver function assessed by ICG R15 test | 3 days after MRI | — |
| Hepatocyte uptake rate | 1 month after MRI | calculated hepatic uptake rate from T1 map sequence at MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse effect after contrast media administration | within an hour after contrast media administration | — |
| T2* value (msec) | 1 month after MRI | T2 star value obtained from Dixon sequence before and after contrast media administration |
| Bile duct excretion of contrast media on hepatobiliary phase | 1 month after MRI | five point scale (1: no visualization, 5: opacification of 2nd branch\ CBD) |
| adverse effect after ICG administration | within an hour after ICG administration | — |
| D | 1 month after MRI | true diffusion coefficient from DWI sequence using multiple b-values (0\ 800sec/mm2) |
| D* | 1 month after MRI | pseudodiffusion coefficient from DWI sequence using multiple b-values (0\ 800sec/mm2) |
| f | 1 month after MRI | perfusion fraction (%) from DWI sequence using multiple b-values (0\ 800sec/mm2) |
| ADC | 1 month after MRI | apparent diffusion coefficient from DWI sequence using multiple b-values (0\ 800sec/mm2) |
| Liver stiffness value (kPa) | 1 month after MRI | liver stiffness from MR elastography |
| Spleen stiffness value (kPa) | 1 month after MRI | spleen stiffness from MR elastography |
Countries
South Korea
Outcome results
None listed