Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation 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: March 19, 2014
Last verified: March 2014
  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 or radiofrequency ablation (RFA).


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: 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

Resource links provided by NLM:


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], hepatocellular uptake index [HUI], liver to spleen ratio (LSR).
    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: 64
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: HCC resection/RFA
Patients who will undergo resection of at least two hepatic segments for HCC or radiofrequency ablation (RFA) 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/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

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/RFA 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 (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.
  Contacts and Locations
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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
Seoul National University Hospital
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's 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: March 19, 2014
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
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Gadolinium ethoxybenzyl DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014