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

February 28, 2021 updated by: Dr. med. Barbara Schellhaas and Prof. Dr. med. Deike Strobel, University Hospital Erlangen

Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • University Hospital Erlangen, Department of Medicine 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients at risk for HCC

Patients with any of the following conditions:

liver cirrhosis of any origin chronic hepatitis B infection chronic hepatitis C infection with advanced fibrosis non-alcoholic steatohepatitis (NASH) hemochromatosis

Interventions: B-mode ultrasound, contrast enhanced ultrasound (CEUS); MRI / histology
Diagnostic test: contrast enhanced ultrasound (CEUS)
CEUS with SonoVue following standardized protocol
Diagnostic test: MRI
CE-MRI following standardized protocol
Diagnostic test: Histology
diagnostic liver biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Investigators

  • Principal Investigator: Barbara Schellhaas, MD, University Hospital Erlangen, Department of Medicine 1
  • Principal Investigator: Deike Strobel, MD, University Hospital Erlangen, Department of Medicine 1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2018

Primary Completion (Actual)

April 6, 2019

Study Completion (Actual)

April 6, 2019

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEGUM CEUS HCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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