Hepatocellular Carcinoma Clinical Trial
— ESCULAPOfficial 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
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 |
Verified date | February 2021 |
Source | University Hospital Erlangen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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) |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Erlangen, Department of Medicine 1 | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University Hospital Erlangen |
Germany,
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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