Trials / Completed
CompletedNCT03405909
Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study
Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 517 (actual)
- Sponsor
- University Hospital Erlangen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Hepatocellular Carcinoma
- Cholangiocarcinoma, Intrahepatic
- Liver Cirrhosis
- Liver Cancer
- Liver Neoplasms
- Liver Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | contrast enhanced ultrasound (CEUS) | CEUS with SonoVue following standardized protocol |
| DIAGNOSTIC_TEST | MRI | CE-MRI following standardized protocol |
| DIAGNOSTIC_TEST | Histology | diagnostic liver biopsy |
Timeline
- Start date
- 2018-04-21
- Primary completion
- 2019-04-06
- Completion
- 2019-04-06
- First posted
- 2018-01-23
- Last updated
- 2021-03-02
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03405909. Inclusion in this directory is not an endorsement.