Hepatocellular Carcinoma, Cholangiocarcinoma, Intrahepatic, Liver Cirrhosis, Liver Cancer, Liver Neoplasms, Liver Diseases
Conditions
Keywords
contrast-enhanced ultrasound, non-invasive diagnosis, focal liver lesion, liver cirrhosis, standardised diagnostic algorithm, intrahepatic cholangiocellular carcinoma, ESCULAP, CEUS LI-RADS, imaging, hepatocellular carcinoma, MRI, diagnostic accuracy, interobserver agreement, Erlanger Synopsis of CEUS for Liver lesion Assessment in Patients at risk, CEUS Liver Imaging Reporting and Data System
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).
Interventions
DIAGNOSTIC_TESTcontrast enhanced ultrasound (CEUS)
CEUS with SonoVue following standardized protocol
DIAGNOSTIC_TESTMRI
CE-MRI following standardized protocol
DIAGNOSTIC_TESTHistology
diagnostic liver biopsy
Sponsors
University Hospital Erlangen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients | 2 years | Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standardisation of CEUS examinations | 2 years | Diagnostic value of an additional standardised examination point in the late phase after 4-6 minutes in lesions without contrast washout after 3 minutes Reference Standard: histology / MRI |
| Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC) | 2 years | Sensitvity, specificity, positive and negative predictive value of contrast-enhanced ultrasound for non-invasive diagnosis of ICC in high-risk patients / differential diagnosis of HCC versus ICC Reference Standard: histology |
| Diagnostic value / dispensability of contrast washout for definite diagnosis of HCC with CEUS | 2 years | Sensitvity, specificity, positive and negative predictive value of arterial hyperenhancement only compared with arterial hyperenhancement followed by contrast washout for non-invasive diagnosis of HCC in high-risk patients Reference Standard: histology / MRI |
| Non-inferiority of CEUS versus MRI for non-invasive diagnosis of HCC | 2 years | Comparison of CEUS and MRI for non-invasive diagnosis of HCC (diagnostic accuracy, interobserver agreement) Reference Standard: histology |
| Influence of histological grading on contrast enhancement behaviour | 2 years | correlation of histological grading and contrast enhancement pattern |
| Comparison of two CEUS-based algorithms | 2 years | ESCULAP versus CEUS LI-RADS (diagnostic accuracy, interobserver agreement) Reference Standard: histology / MRI |
Countries
Germany
Outcome results
None listed