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

NCT01490203 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2018-03-23

No results posted yet for this study

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).

Conditions

  • Carcinoma, Hepatocellular
  • Liver Dysfunction

Interventions

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Seoul St. Mary's Hospital

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Chonnam National University Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jeong Min Lee, MD, PhD · Seoul National University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-02-28
Completion
2016-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490203 on ClinicalTrials.gov