Clinical trial NCT03405909: Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study
Official title: Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma, Intrahepatic
Liver Cirrhosis
Liver Cancer
Liver Neoplasms
Liver Diseases
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
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients
timeFrame: 2 years
Secondary outcomes:
measure: Diagnostic value / dispensability of contrast washout for definite diagnosis of HCC with CEUS
timeFrame: 2 years
measure: Standardisation of CEUS examinations
timeFrame: 2 years
measure: Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC)
timeFrame: 2 years
measure: Comparison of two CEUS-based algorithms
timeFrame: 2 years
measure: Non-inferiority of CEUS versus MRI for non-invasive diagnosis of HCC
timeFrame: 2 years
measure: Influence of histological grading on contrast enhancement behaviour
timeFrame: 2 years
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen, Department of Medicine 1
state: Bavaria
Study officials:
affiliation: University Hospital Erlangen, Department of Medicine 1
name: Barbara Schellhaas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Erlangen, Department of Medicine 1
name: Deike Strobel, MD
role: PRINCIPAL_INVESTIGATOR
References: