Overview

This trial is active, not recruiting.

Conditions carcinoma, hepatocellular, liver dysfunction
Treatments gd-eob-dtpa, mri
Sponsor Seoul National University Hospital
Collaborator Bayer
Start date December 2011
End date February 2014
Trial size 71 participants
Trial identifier NCT01490203, LIFE_ISS_2011

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
gd-eob-dtpa Gadoxetic Acid Disodium
Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.
mri
Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver. Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection.
Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
gd-eob-dtpa Gadoxetic Acid Disodium
Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.
mri
Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test. Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection.

Primary Outcomes

Measure
Correlation of hepatic extraction fraction (HEF) of future remnant liver function (RLF) obtained from Gd-EOB-DTPA enhanced MRI with postoperative ICG R15 clearance test results
time frame: 3 days (upto 5 days) after surgery

Secondary Outcomes

Measure
Correlation of various functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and clinical liver function tests obtained before and after surgical resection
time frame: within 7 days before, and 3 to 5 days after surgery
Analysis of clinical and MRI parameters of postoperative complication and morbidity
time frame: upto 3 months (plus minus 1 week) after discharge
Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors
time frame: within 3 days of ICG R15 test

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Pre-Surgical Treatment or Radio Frequency Ablation (RFA) Evaluation of Future Remnant Liver Function Using Gd-EOB-DTPA Enhanced MRI in Patients Undergoing Hepatic Resection /RFA for Hepatocellular Carcinoma
Principal investigator Jeong Min Lee, MD, PhD
Description 1. 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. 2. 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. 3. 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. 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 HCC before major hepatic resection/RFA.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.