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Recruiting 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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05716620). StuddyBuddy aggregates publicly available trial information.