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Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection of Hepatocellular Carcinoma (LiFE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bayer
Seoul St. Mary's Hospital
Asan Medical Center
Chonnam National University Hospital
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01490203
First received: December 7, 2011
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Carcinoma, Hepatocellular
Liver Dysfunction
 Drug: Gd-EOB-DTPA
Procedure: MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Evaluation of Future Remnant Liver Function Using Gd-EOB-DTPA Enhanced Magnetic Resonance Imaging in Patients Undergoing Hepatic Resection for Hepatocellular Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    1. Functional parameters derived from Gd-EOB-DTPA enhanced MRI include hepatic extraction fraction [HEF], input-relative blood flow [irBF] and mean transit time [MTT], hepatocellular uptake index [HUI], L20, S20, Cmax, Tmax, T1/2.
    2. Volumetric parameters include global liver volume and remnant liver volume.
    3. Clinical liver function tests include ICG R15, MELD score and Child-Pugh score.
    4. ICG R15 [Indocyanine green retention at 15 minutes, %] test will be performed within 3 days of preoperative MRI and 3 days after surgical resection.

  • Analysis of clinical and MRI parameters of postoperative complication and morbidity [ Time Frame: upto 3 months (plus minus 1 week) after discharge ] [ Designated as safety issue: No ]

    1. Clinical parameters refer to the following.

      • Frequency of POD#5 days 50-50 criteria
      • Evaluation of operation related complication
      • Incidence of hepatic failure or death
    2. Functional and volumetric MRI parameters of patients with postoperative complication and morbidity will be evaluated.
    3. Correlation of MRI parameters with laboratory liver function tests.

  • Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors [ Time Frame: within 3 days of ICG R15 test ] [ Designated as safety issue: No ]
    1. Correlation of functional parameters derived from Gd-EOB-DTPA enhanced MRI with ICG R15
    2. Correlation of functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI
    3. Correlation of volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and ICG15
    4. Comparison of functional MRI parameters between potential liver donors and patients undergoing hepatic resection for HCC.


Estimated Enrollment: 54
Study Start Date: December 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: HCC resection
Patients who will undergo resection of at least two hepatic segments for HCC
 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.
Other Names:
  • Gadoxetic Acid Disodium
  • Primovist/Eovist
  • BAY86-4873
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.
Group 2: Potential liver donor
Potential liver donors with normal hepatic function
 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.
Other Names:
  • Gadoxetic Acid Disodium
  • Primovist/Eovist
  • BAY86-4873
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.

Detailed Description:
  1. Preoperative 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Group 1: Patients who will undergo hepatic resection for HCC. Group 2: Potential liver donors with normal hepatic function.

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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490203

Locations
Korea, Republic of
Cheonnam University Hwasun Hospital
Hwasun-Gun, Cheonnam province, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Bayer
Seoul St. Mary's Hospital
Asan Medical Center
Chonnam National University Hospital
Investigators
Principal Investigator: Jeong Min Lee, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jeong Min Lee, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01490203     History of Changes
Other Study ID Numbers: LIFE_ISS_2011
Study First Received: December 7, 2011
Last Updated: November 13, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Gd-EOB-DTPA
MRI
Hepatectomy
Hepatocellular Carcinoma
Liver Function Tests

Additional relevant MeSH terms:
Carcinoma
Liver Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Pentetic Acid
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents

ClinicalTrials.gov processed this record on May 21, 2013