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

Hepatocellular Carcinoma Clinical Trial

— ESCULAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405909
• Other study ID #: DEGUM CEUS HCC
• Status: Completed
• Start date: April 21, 2018
• Est. completion date: April 6, 2019

Study information

• Verified date: February 2021
• Source: University Hospital Erlangen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: April 6, 2019
• Est. primary completion date: April 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• contrast enhanced ultrasound (CEUS)
CEUS with SonoVue following standardized protocol
• MRI
CE-MRI following standardized protocol
• Histology
diagnostic liver biopsy

Locations

Country	Name	City	State
Germany	University Hospital Erlangen, Department of Medicine 1	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	Comparison of two CEUS-based algorithms	ESCULAP versus CEUS LI-RADS (diagnostic accuracy, interobserver agreement) Reference Standard: histology / MRI	2 years
Secondary	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	2 years
Secondary	Influence of histological grading on contrast enhancement behaviour	correlation of histological grading and contrast enhancement pattern	2 years

External Links

•   Homepage of the DEGUM (Funding Organization)