NCT03405909

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 21, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2019

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

January 12, 2018

Last Update Submit

February 28, 2021

Conditions

Hepatocellular CarcinomaCholangiocarcinoma, IntrahepaticLiver CirrhosisLiver CancerLiver NeoplasmsLiver Diseases

Keywords

contrast-enhanced ultrasoundnon-invasive diagnosisfocal liver lesionliver cirrhosisstandardised diagnostic algorithmintrahepatic cholangiocellular carcinomaESCULAPCEUS LI-RADSimaginghepatocellular carcinomaMRIdiagnostic accuracyinterobserver agreementErlanger Synopsis of CEUS for Liver lesion Assessment in Patients at riskCEUS Liver Imaging Reporting and Data System

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    2 years

  • Standardisation of CEUS examinations

    2 years

  • Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC)

    2 years

  • Comparison of two CEUS-based algorithms

    2 years

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

    2 years

  • +1 more secondary outcomes

Study Arms (1)

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)Diagnostic Test: MRIDiagnostic Test: Histology

Interventions

contrast enhanced ultrasound (CEUS)DIAGNOSTIC_TEST

CEUS with SonoVue following standardized protocol

Patients at risk for HCC
MRIDIAGNOSTIC_TEST

CE-MRI following standardized protocol

Patients at risk for HCC
HistologyDIAGNOSTIC_TEST

diagnostic liver biopsy

Patients at risk for HCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • high risk for HCC
  • focal liver lesion on B-mode ultrasound

You may not qualify if:

  • pre-treated HCC lesion
  • systemic therapy for HCC (sorafenib, regorafenib and others)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen, Department of Medicine 1

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularCholangiocarcinomaLiver CirrhosisLiver NeoplasmsLiver Diseases

Interventions

Shadowing Technique, Histology

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Staining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative Techniques

Study Officials

  • Barbara Schellhaas, MD

    University Hospital Erlangen, Department of Medicine 1

    PRINCIPAL INVESTIGATOR

  • Deike Strobel, MD

    University Hospital Erlangen, Department of Medicine 1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

April 21, 2018

Primary Completion

April 6, 2019

Study Completion

April 6, 2019

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)