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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03405909
Other study ID # DEGUM CEUS HCC
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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