Clinical trial · Observational
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
NCT03405909CI-TRIAL-00050408ESCULAPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma, Intrahepatic | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| contrast enhanced ultrasound (CEUS) | Diagnostic Test | — | UNRESOLVED |
| Histology | Diagnostic Test | — | UNRESOLVED |
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients at risk for HCC
- description
- Patients with any of the following conditions: liver cirrhosis of any origin chronic hepatitis B infection chronic hepatitis C infection with advanced fibrosis non-alcoholic steatohepatitis (NASH) hemochromatosis Interventions: B-mode ultrasound, contrast enhanced ultrasound (CEUS); MRI / histology
- interventionNames
- Diagnostic Test: contrast enhanced ultrasound (CEUS)
- Diagnostic Test: MRI
- Diagnostic Test: Histology
Primary outcomes (1)
- measure
- Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients
- timeFrame
- 2 years
- description
- Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.