Skip to main content
OpenTrials
Completed

NCT Number: NCT03405909

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Cholangiocarcinoma, Intrahepatic Digestive System Diseases Digestive System Neoplasms Fibrosis Liver Cancer Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen, Department of Medicine 1

Erlangen, Bavaria, 91054, Germany

About this study

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:

  • whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS
  • 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
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

contrast enhanced ultrasound (CEUS)

Diagnostic Test

CEUS with SonoVue following standardized protocol

MRI

Diagnostic Test

CE-MRI following standardized protocol

Histology

Diagnostic Test

diagnostic liver biopsy

Primary outcomes

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

    Time frame: 2 years

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

Secondary outcomes

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

    Time frame: 2 years

    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. Standardisation of CEUS examinations

    Time frame: 2 years

    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

  3. Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC)

    Time frame: 2 years

    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

  4. Comparison of two CEUS-based algorithms

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  6. Influence of histological grading on contrast enhancement behaviour

    Time frame: 2 years

    correlation of histological grading and contrast enhancement pattern

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Registry information

Official study 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

Acronym: ESCULAP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.