Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

NCT02854371 | Completed Phase 4 DMC

• 1 other identifier: SNUH-2015-3375
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Keywords

gadoxetic acid; T1 map; MRI

Outcome Measures

Primary Outcomes (1)

• Liver function assessed by hepatocyte fraction

  hepatocyte fraction obtained by T1 map sequence

  1 month after MRI

Secondary Outcomes (2)

• Liver function assessed by ICG R15 test

  3 days after MRI

• Hepatocyte uptake rate

  1 month after MRI

Other Outcomes (10)

• Liver stiffness value (kPa)

  1 month after MRI

• Spleen stiffness value (kPa)

  1 month after MRI

• adverse effect after contrast media administration

  within an hour after contrast media administration

Study Arms (1)

CLD and LC

EXPERIMENTAL

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; Drug: ICG R15

Interventions

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.

Also known as: Primovist, Eovist

CLD and LC

ICG R15 DRUG

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

Also known as: Indocyanine green retention test

CLD and LC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with chronic liver disease or liver cirrhosis
• clinically scheduled for gadoxetic acid enhanced liver MRI
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Fibrosis

Interventions

gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: gadoxetic acid MRI and ICG R15 test

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: August 3, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: May 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)