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

University Hospital Erlangen517 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

517

Conditions

Hepatocellular Carcinoma Cholangiocarcinoma, Intrahepatic Liver Cirrhosis Liver Cancer Liver Neoplasms Liver Diseases

Interventions

contrast enhanced ultrasound (CEUS)DIAGNOSTIC_TEST

CEUS with SonoVue following standardized protocol

MRIDIAGNOSTIC_TEST

CE-MRI following standardized protocol

HistologyDIAGNOSTIC_TEST

diagnostic liver biopsy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Erlangen, Department of Medicine 1

Erlangen, Bavaria, Germany

Outcomes

Primary Outcomes

Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients

Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI

Time frame: 2 years

Secondary Outcomes

Diagnostic value / dispensability of contrast washout for definite diagnosis of HCC with CEUS

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

Time frame: 2 years

Standardisation of CEUS examinations

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

Time frame: 2 years

Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC)

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

Time frame: 2 years

Comparison of two CEUS-based algorithms

ESCULAP versus CEUS LI-RADS (diagnostic accuracy, interobserver agreement) Reference Standard: histology / MRI

Time frame: 2 years

Non-inferiority of CEUS versus MRI for non-invasive diagnosis of HCC

Comparison of CEUS and MRI for non-invasive diagnosis of HCC (diagnostic accuracy, interobserver agreement) Reference Standard: histology

Data from ClinicalTrials.gov

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