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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
612
Undergo CEUS
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
Sensitivity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval 95% confidence interval for HCC diagnosis using CEUS LR-5 classification
A value of 67% for sensitivity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
Time frame: Up to 12 months
Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval
A value of 91% for specificity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
Time frame: Up to 12 months
Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval
A value of 93% for Positive Predicative Value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
Time frame: Up to 12 months
Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval
A value of 60% for Negative predictive value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
Time frame: Up to 12 months
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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
...and 1 more locations