NCT03318380

Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis

Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 612 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	Dynamic Contrast-Enhanced Ultrasound Imaging	Undergo CEUS

Timeline

• Start date: 2018-01-19
• Primary completion: 2021-08-31
• Completion: 2022-11-03
• First posted: 2017-10-23
• Last updated: 2025-05-18

Locations

11 sites across 6 countries: United States, Canada, France, Italy, Switzerland, United Kingdom