- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01490203
Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma (LiFE)
March 22, 2018 updated by: Jeong Min Lee, Seoul National University Hospital
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- 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.
- 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.
- 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.
Study Type
Observational
Enrollment (Actual)
71
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Cheonnam Province
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Hwasun-Gun, Cheonnam Province, Korea, Republic of
- Cheonnam University Hwasun Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Patients with the diagnosis of HCC based on noninvasive diagnostic criteria of HCC proposed by 2010 AASLD
- Surgical resection of hepatic resection greater than 2 Couinaud segments (including total hepatectomy for transplantation) or radiofrequency ablation is planned
- Patients who provided the informed consent
Exclusion Criteria:
- Patients younger than 18 yrs old
- Patients who received hepatic surgery prior to this study
- Patients who underwent TACE or RFA for greater than 2 segments within 3 months prior to this study
- Patients who received radiation treatment including the liver or systemic chemotherapy
- Patients who underwent contrast enhanced liver MRI within 3 days prior to this study
- Patients with severe renal dysfunction (Cr .2.5 mg/dL or GFR < 30mL/min)
- Patients with hypersensitivity to gadolinium
- Patients with uncorrectable hypokalemia
- Pregnant women, or reproductive age women who will not agree with contraception during this study period.
- Patients with mental disorder which will interfere with voluntary agreement
- Patients who have any contraindication to MRI (cardiac pacemaker, ferromagnetic implants, etc.)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1: HCC resection/RFA
Patients who will undergo resection of at least two hepatic segments for HCC or radiofrequency ablation (RFA) for HCC and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
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Other Names:
Other Names:
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Group 2: Potential liver donor
Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment
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3 days (upto 5 days) after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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within 7 days before, and 3 to 5 days after surgery
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Analysis of clinical and MRI parameters of postoperative complication and morbidity
Time Frame: upto 3 months (plus minus 1 week) after discharge
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upto 3 months (plus minus 1 week) after discharge
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Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors
Time Frame: within 3 days of ICG R15 test
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within 3 days of ICG R15 test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 7, 2011
First Submitted That Met QC Criteria
December 8, 2011
First Posted (ESTIMATE)
December 12, 2011
Study Record Updates
Last Update Posted (ACTUAL)
March 23, 2018
Last Update Submitted That Met QC Criteria
March 22, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Neoplasms
- Liver Diseases
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Anticoagulants
- Antidotes
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Calcium Chelating Agents
- Edetic Acid
- Pentetic Acid
Other Study ID Numbers
- LIFE_ISS_2011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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