A prospective open intra-individual comparative cohort study to investigate the performance characteristics of Gadoxetic Acid (Primovist®)-enhanced MRI and Ultrasonography for the surveillance of early stage HCC in patients with liver cirrhosis at high-risk
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000277
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 423
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 includes any of followings;
1) The identification of splenomegaly on USG, CT, or MRI examinations with typical features of cirrhosis
2) 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-HCV or 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
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
- Significant medical comorbidities in which survival is predicted to be less than 3 years
- Estimated GFR < 30 mL/min/1.73m2
- Estimated GFR by Modification of Diet in Renal Disease (MDRD) equation 25; GFR (ml/min/1.73 m2) = 175 × serum creatinine?1.154 × age?0.203 × 1.212 (if black) × 0.742 (if female)
- 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.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The detection sensitivity of early stage HCC
- Secondary Outcome Measures
Name Time Method The detection sensitivity of patients with early stage HCC;The detection sensitivity of very early stage HCC ;The detection sensitivity of all stage HCC;The cost-effectiveness for each surveillance tests;The detection specificity for all stage HCC