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).

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).

Inclusion Criteria:

• high risk for HCC
• focal liver lesion on B-mode ultrasound

Exclusion Criteria:

• pre-treated HCC lesion
• systemic therapy for HCC (sorafenib, regorafenib and others)

High-risk patients for HCC according to German national guidelines (AWMF / DGVS): 1- cirrhosis of any origin; 2- chronic hepatitis B infection; 3 - chronic hepatitis C infection; 4 - non-alcoholic steatohepatitis (NASH); 5 - hereditary hemochromatosis