Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma (LiFE)

Seoul National University

Status

Completed

Conditions

Carcinoma, Hepatocellular

Liver Dysfunction

Treatments

Procedure: MRI

Drug: Gd-EOB-DTPA

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01490203

LIFE_ISS_2011

Details and patient eligibility

About

The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with Hepatocellular Carcinoma (HCC) before major hepatic resection or radiofrequency ablation (RFA).

Full description

Preoperative/RFA assessment of remnant liver function is important for avoiding posthepatectomy liver failure. However, the function of the future remnant is decreased in patients with chronic liver disease or cirrhosis, compared to that of healthy patients with an equal volume. Therefore, volume-based estimation of hepatic reserve function is inadequate for patients with hepatic dysfunction.
Standard clinical liver function tests, such as ICG clearance rate or Child-Pugh score, provides measurements of the global hepatic function, but cannot evaluate the functional distribution in the liver. Gd-EOB-DTPA (Gadoxetic acid, Primovist®, Bayer Schering) enhanced MRI has been recently demonstrated to have the potential to be an imaging-based liver function test, with the possibility to detect functional differences on a regional or even segmental level.
Gd-EOB-DTPA-enhanced liver MRI may be able to assess not only global but also segmental liver function in patients with hepatocellular carcinoma (HCC) who have a relatively high risk for developing liver failure after surgical resection due to coexistent hepatic damage by chronic viral hepatitis and/or cirrhosis preoperatively.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients with the diagnosis of HCC based on noninvasive diagnostic criteria of HCC proposed by 2010 AASLD
Surgical resection of hepatic resection greater than 2 Couinaud segments (including total hepatectomy for transplantation) or radiofrequency ablation is planned
Patients who provided the informed consent

Exclusion criteria

Patients younger than 18 yrs old
Patients who received hepatic surgery prior to this study
Patients who underwent TACE or RFA for greater than 2 segments within 3 months prior to this study
Patients who received radiation treatment including the liver or systemic chemotherapy
Patients who underwent contrast enhanced liver MRI within 3 days prior to this study
Patients with severe renal dysfunction (Cr .2.5 mg/dL or GFR < 30mL/min)
Patients with hypersensitivity to gadolinium
Patients with uncorrectable hypokalemia
Pregnant women, or reproductive age women who will not agree with contraception during this study period.
Patients with mental disorder which will interfere with voluntary agreement
Patients who have any contraindication to MRI (cardiac pacemaker, ferromagnetic implants, etc.)
Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.

Trial design

71 participants in 2 patient groups

Group 1: HCC resection/RFA

Description:

Patients who will undergo resection of at least two hepatic segments for HCC or radiofrequency ablation (RFA) for HCC and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI

Treatment:

Drug: Gd-EOB-DTPA

Procedure: MRI

Drug: Gd-EOB-DTPA

Group 2: Potential liver donor

Description:

Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI

Treatment:

Drug: Gd-EOB-DTPA

Procedure: MRI

Drug: Gd-EOB-DTPA