A prospective randomized comparative cohort study to investigate abbreviated MRI using Gadoxetic acid and ultrasonography for surveillance of early stage HCC in patients at high risk for HCC

Asan Medical Center0 个研究点目标入组 806 人开始时间: 待定最近更新: 2023年1月10日

适应症

试验速览

暂无简介。

•1. 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 Ultrasonography, CT, or MRI examinations with typical features of liver cirrhosis
•(2) The identification of esophageal or gastric varices on endoscopic examination
•2. Older than 20 years of age
•3. Absence of previous or current history of hepatocellular carcinoma within 6 months prior to screening
•4. Eastern Cooperative Oncology Group performance status of 0-2
•5. Patient is able to comply with scheduled visits, evaluation plans, and other study procedures.
•6. Patient is willing to provide written informed consent

•1. Active or suspected cancer other than hepatocellular carcinoma, or a history of malignancy where the risk of recurrence is equal or higher than 20% within 2 years
•2. Significant medical comorbidities in which survival is predicted to be less than 3 years
•3. Estimated glomerular filtration rate < 30 mL/min/1.73m^2
•(1) Estimated glomerular filtration rate by Modification of Diet in Renal Disease equation = 175 × serum creatinine-1.154 × age-0.203 × 1.212 (if black) × 0.742 (if female)
•4. Budd-Chiari Syndrome
•5. Precautions for MRI (cardiac pacemaker, severe claustrophobia that may interfere with protocol compliance)
•6. 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.

发起方