Status:
COMPLETED
Gadoxetic Acid-MRI Versus Ultrasonography for the Surveillance of Hepatocellular Carcinoma in High-risk Patients
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Bayer
Conditions:
Cirrhosis of Liver
Eligibility:
All Genders
20+ years
Brief Summary
Current practice guidelines recommend surveillance for hepatocellular carcinoma (HCC) in liver cirrhosis patients with ultrasonography (USG) every 6 months. However, with the advancement of cirrhosis,...
Detailed Description
Hepatocellular carcinoma (HCC) is currently the third leading cause of cancer-related deaths worldwide. Cirrhosis, particularly when related to viral hepatitis, is the most notable risk factor for HCC...
Eligibility Criteria
Inclusion
- Patients with liver cirrhosis with the 1 year risk of HCC of 5% or higher meeting all of following criteria;
- The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
- 1\) Histologically by liver biopsy;
- 2\) Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
- Evidence of portal hypertension, including any of followings;
- The identification of splenomegaly on USG, CT, or MRI examinations with typical features of cirrhosis
- The identification of esophageal or gastric varices on endoscopic examination
- High Risk Index (\>=2.33); Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus \[HCV\] or hepatitis B surface antigen \[HBsAg\] is positive).
- Older than 20 years of age
- Absence of previous or current history of HCC
- Absence of HCC should be identified by liver USG, dynamic CT, or contrast-enhanced MRI within 6 months prior to screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- Patient is able to comply with scheduled visits, evaluation plans, and other study procedures.
- Patient is willing to provide written informed consent
Exclusion
- Presence of any of following criteria;
- Active or suspected cancer other than HCC, or a history of malignancy where the risk of recurrence is \>20% within 2 years
- Child-Pugh score \>9
- Significant medical comorbidities in which survival is predicted to be less than 3 years
- Estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73m2
- Precautions for MRI (cardiac pacemaker, ferromagnetic implants, etc.)
- Severe claustrophobia that may interfere with protocol compliance.
- Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completing the study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT01446666
Start Date
November 1 2011
End Date
December 1 2014
Last Update
February 1 2019
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 135-837