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

Carcinoma, Hepatocellular Clinical Trial

— LiFE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490203
• Other study ID #: LIFE_ISS_2011
• Status: Completed
• First received: December 7, 2011
• Last updated: March 22, 2018
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (RFA).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Diseases
• Liver Dysfunction

Intervention

Drug:
• Gd-EOB-DTPA
Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.
• Gd-EOB-DTPA
Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.

Procedure:
• MRI
Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver. 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.
• MRI
Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test. 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.

Locations

Country	Name	City	State
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

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Bayer, Chonnam National University Hospital, Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 days (upto 5 days) after surgery
Secondary	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	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).; Volumetric parameters include global liver volume and remnant liver volume.; Clinical liver function tests include ICG R15, MELD score and Child-Pugh score.; ICG R15 [Indocyanine green retention at 15 minutes, %] test will be performed within 3 days of preoperative MRI and 3 days after surgical resection.	within 7 days before, and 3 to 5 days after surgery
Secondary	Analysis of clinical and MRI parameters of postoperative complication and morbidity	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; Functional and volumetric MRI parameters of patients with postoperative complication and morbidity will be evaluated.; Correlation of MRI parameters with laboratory liver function tests.	upto 3 months (plus minus 1 week) after discharge
Secondary	Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors	Correlation of functional parameters derived from Gd-EOB-DTPA enhanced MRI with ICG R15; Correlation of functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI; Correlation of volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and ICG15; Comparison of functional MRI parameters between potential liver donors and patients undergoing hepatic resection for HCC.	within 3 days of ICG R15 test