NCT01490203

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Carcinoma, Hepatocellular
• Liver Dysfunction

Interventions

Type	Name	Description
DRUG	Gd-EOB-DTPA	1. Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver. 2. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.
DRUG	Gd-EOB-DTPA	1. Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test. 2. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.
PROCEDURE	MRI	1. Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver. 2. 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.
PROCEDURE	MRI	1. Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test. 2. 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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-02-01
• Completion: 2016-12-01
• First posted: 2011-12-12
• Last updated: 2018-03-23

Locations

4 sites across 1 country: South Korea