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

Asan Medical Center0 个研究点目标入组 423 人开始时间: 待定最近更新: 2019年3月11日

适应症

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•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.

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