Overview

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

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Seoul National University Hospital
Collaborators:
Asan Medical Center
Bayer
Chonnam National University Hospital
Seoul St. Mary's Hospital
Treatments:
Edetic Acid
Liver Extracts
Pentetic Acid
Criteria
Inclusion Criteria:

1. Patients with the diagnosis of HCC based on noninvasive diagnostic criteria of HCC
proposed by 2010 AASLD

2. Surgical resection of hepatic resection greater than 2 Couinaud segments (including
total hepatectomy for transplantation) or radiofrequency ablation is planned

3. Patients who provided the informed consent

Exclusion Criteria:

1. Patients younger than 18 yrs old

2. Patients who received hepatic surgery prior to this study

3. Patients who underwent TACE or RFA for greater than 2 segments within 3 months prior
to this study

4. Patients who received radiation treatment including the liver or systemic chemotherapy

5. Patients who underwent contrast enhanced liver MRI within 3 days prior to this study

6. Patients with severe renal dysfunction (Cr .2.5 mg/dL or GFR < 30mL/min)

7. Patients with hypersensitivity to gadolinium

8. Patients with uncorrectable hypokalemia

9. Pregnant women, or reproductive age women who will not agree with contraception during
this study period.

10. Patients with mental disorder which will interfere with voluntary agreement

11. Patients who have any contraindication to MRI (cardiac pacemaker, ferromagnetic
implants, etc.)

12. 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.