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NCT05716620
Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 40 Years – 65 Years
Enrollment: 380
Sponsor: Postgraduate Institute of Medical Education and Research, Chandigarh
Location: India
Summary
The goal of this study is Utility of abbrevational magnetic resonance imaging as a screening tool for hepatocellular carcinoma in cirrhotic patients.The primary objective of the study is:• HCC detection rate of US vs AMRI in cirrhotic patientsThe secondary objective of the study are:False referral rate of US vs AMRI: false referral will be defined as lack of HCC on complete MRI despite a positive US or AMRI.Positive predictive value of US vs AMRI: The positive predictive value will be defined as the number of patients with true positive results in patients with positive US/AMRI.Participants will be evaluated by two rounds of screening 6 months apart using paired US and non-enhanced AMRI.
Eligibility Criteria
Inclusion Criteria:Age>40 yearsPresence of cirrhosisAnnual risk of HCC >5%No HCC on pre-enrollment imaging not more than 6 months back.Risk factors including diabetes mellitus, metabolic syndrome, family history of HCC.Exclusion Criteria:Child C statusDiagnosed or follow up case of HCCOther malignanciesPregnancy, lactationContraindications to MRI (pacemaker, cochlear implant, claustrophobia)Chronic renal disease or contrast allergy precluding administration of intravenous MRI contrast agent (for reference standard)
Source: ClinicalTrials.gov (NCT05716620). StuddyBuddy aggregates publicly available trial information.