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Carcinoma, HepatocellularLiFENCT01490203

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

An observational study of Carcinoma, Hepatocellular and Liver Dysfunction, run by Seoul National University Hospital at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Carcinoma, Hepatocellular, Liver Dysfunction
What is being tested?
Gd-EOB-DTPA and MRI
How many people
71 participants
Where
4 sitesSouth Korea
Study dates
Dec 2011to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Cheonnam University Hwasun Hospital

    Hwasun-Gun, Cheonnam Province

  • Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

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

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).

Read the 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.

Being tested
Gd-EOB-DTPA, MRI
Keywords
Gd-EOB-DTPA, MRI, Hepatectomy, Hepatocellular Carcinoma, Liver Function Tests
Medical subject headings
Carcinoma, Hepatocellular, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gd-EOB-DTPADrug

    Also called Gadoxetic Acid Disodium, Primovist/Eovist, BAY86-4873

    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.

  • Gd-EOB-DTPADrug

    Also called Gadoxetic Acid Disodium, Primovist/Eovist, BAY86-4873

    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.

  • MRIProcedure or surgery

    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.

  • MRIProcedure or surgery

    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.
Study groups in NCT01490203
Study groupRoleWhat they receive
Group 1: HCC resection/RFAPatients 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
Receives: Drug: Gd-EOB-DTPA; Procedure: MRI
Group 2: Potential liver donorPotential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
Receives: Drug: Gd-EOB-DTPA; Procedure: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment

    Measured: 3 days (upto 5 days) after surgery

Secondary outcomes (3)

  1. 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

    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.

    Measured: within 7 days before, and 3 to 5 days after surgery

  2. Analysis of clinical and MRI parameters of postoperative complication and morbidity

    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
    1. Functional and volumetric MRI parameters of patients with postoperative complication and morbidity will be evaluated.
    2. Correlation of MRI parameters with laboratory liver function tests.

    Measured: upto 3 months (plus minus 1 week) after discharge

  3. Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors

    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.

    Measured: within 3 days of ICG R15 test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionFeb 2014
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01490203
Sponsor's protocol ID
LIFE_ISS_2011
Acronym
LiFE
Status last verified
Mar 2018
First submitted
7 Dec 2011
Last updated
23 Mar 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Yoon JH, Choi JI, Jeong YY, Schenk A, Chen L, Laue H, Kim SY, Lee JM. Pre-treatment estimation of future remnant liver function using gadoxetic acid MRI in patients with HCC. J Hepatol. 2016 Dec;65(6):1155-1162. doi: 10.1016/j.jhep.2016.07.024. Epub 2016 Jul 28.

    PubMed 27476767

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Hepatocellular and Liver Dysfunction, run by Seoul National University Hospital at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01490203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.

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