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Brief Title: Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
Official Title: Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC
Study ID: NCT03318380
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California San Diego, San Diego, California, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center, Philadelphia, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Swedish Medical Center, Seattle, Washington, United States
University of Calgary, Calgary, , Canada
University of Paris, Paris, , France
University of Bologna, Bologna, , Italy
University of Bern, Bern, , Switzerland
King's College Hospital, London, , United Kingdom
Name: Andrej Lyshchik, MD, PhD
Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
Role: PRINCIPAL_INVESTIGATOR