Spots Global Cancer Trial Database for Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study

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Trial Identification

Brief Title: Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study

Official Title: Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study

Study ID: NCT03405909

Conditions

Hepatocellular Carcinoma

Cholangiocarcinoma, Intrahepatic

Interventions

contrast enhanced ultrasound (CEUS)

MRI

Histology

Study Description

Brief Summary: Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients. The study is funded by the German Society for Ultrasound in Medicine (DEGUM).

Detailed Description: To date, CEUS criteria for non-invasive diagnosis of HCC include arterial phase hyperenhancement, followed by contrast washout in the portal venous or late phase. We would like to investigate the following points: 1. whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS 2. whether a further clearly-defined point of assessment in the late phase after 4-6 minutes is of additional diagnostic value in focal liver lesions showing no contrast washout after 3 minutes 3. diagnostic value of CEUS-based standardised diagnostic algorithms (ESCULAP = Erlanger Synopsis of Contrast Enhanced Ultrasound for Liver lesion Assessment in Patients at risk; CEUS LI-RADS = Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System) for non-invasive diagnosis of HCC in high-risk patients (diagnostic accuracy, interobserver-variability, feasability in clinical Routine).