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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-21

Study Completion Date

2019-04-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of CEUS as a Secondary Diagnostic Modality

NCT04494022

Hepatocellular Carcinoma

UNKNOWN NA

Contrast Enhanced Ultrasound (CEUS) in Atypical Liver Nodules in Patients With Chronic Liver Disease

NCT05772403

Hepatocellular Carcinoma

COMPLETED

Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

NCT04212273

Hepatocellular Cancer Liver Cirrhoses Diagnoses Disease

UNKNOWN NA

The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods

NCT06876805

Focal Liver Lesion

RECRUITING

Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC

NCT04212286

Hepatocellular Cancer Liver Cirrhoses Diagnoses Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Cholangiocarcinoma, Intrahepatic Liver Cirrhosis Liver Cancer Liver Neoplasms Liver Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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