This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03318380.
PRIMARY OBJECTIVES:
I. To evaluate the sensitivity, specificity, positive and negative predictive values of contrast-enhanced ultrasound (CEUS) for diagnosis of hepatocellular carcinoma (HCC) in patients at risk for HCC in a multicenter setting.
SECONDARY OBJECTIVES:
I. To validate CEUS Liver Imaging Reporting and Data System (LI-RADS) and determine the prevalence of HCC in each CEUS LI-RADS category.
II. To evaluate inter-reader reliability of CEUS for HCC diagnosis.
III. To evaluate covariates that might limit diagnostic performance of CEUS for HCC diagnosis.
OUTLINE:
Patients receive sulfur hexafluoride lipid microspheres intravenously (IV) and undergo CEUS imaging over 10 minutes.
After completion of study, patients are followed up for 12 months.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorAndrej Lyshchik
