Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Liver Cirrhosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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 Imagin...
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.
Tracking Information
- NCT #
- NCT03318380
- Collaborators
- National Cancer Institute (NCI)
- GE Healthcare
- Bracco Diagnostics, Inc
- Investigators
- Principal Investigator: Andrej Lyshchik, MD, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University