Spots Global Cancer Trial Database for Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma
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Trial Identification
Brief Title: Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma
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
Study ID: NCT01490203
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Cheonnam University Hwasun Hospital, Hwasun-Gun, Cheonnam Province, Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Jeong Min Lee, MD, PhD
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
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