Acquisition and Frequency Spectroscopic Evaluation of Broadband Clinical Ultrasound Raw Data for Liver Cirrhosis and Focal Pathologies Using Neural Networks for Tissue and Pathology Differentiation

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test the performance of neuronal networks trained on ultrasonic raw Data (=radiofrequency data) for the assessment of liver diseases in patients undergoing a clinical ultrasound examination. The general feasibility is currently evaluated in a retrospective cohort. The main questions the study aims to answer are: * Can a neuronal network trained on RF Data perform equally good as elastography in the assessment of diffuse liver diseases? * Can a neuronal network trained on RF Data perform better than a neuronal network trained on b-mode images in the assessment of diffuse liver diseases? * Can a neuronal network trained on RF Data distinguish focal pathologies in the liver from healthy tissue? To answer these questions participants with a clinically indicated fibroscan will undergo: * a clinical elastography in Case ob suspected diffuse liver disease * a reliable ground truth (if normal ultrasound is not sufficient e.g. contrast enhanced ultrasound, biopsy, MRI or CT) in case of focal liver diseases, depending on the standard routine of the participating center * a clinical ultrasound examination during which b-mode images and the corresponding RF-Data sets are captured

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• scheduled for an ultrasound investigation by an independent physician

• signed declaration of consent

Locations
Other Locations
Germany
Diakonissen Hospital Dresden
RECRUITING
Dresden
University Hospital
RECRUITING
Dresden
University Hospital Halle (Saale)
RECRUITING
Halle
University Hospital Leipzig
RECRUITING
Leipzig
Contact Information
Primary
Moritz Herzog, MD
moritz.herzog@ukdd.de
0049 351 458 11501
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Experimental: Elastography
Collection of ultrasound data and elastography data from patients who were clinically planned for elastography
Experimental: Focal lesion
Collection of ultrasound data of the suspected lesion and a definitive diagnosis based on either normal ultrasound investigation or if not sufficient additional investigations like CEUS, Biopsy, MRI or CT. This further investigation should be in accordance to normal clinical routine of the centers to differentiate focal lesions.
Related Therapeutic Areas
Sponsors
Leads: Technische Universität Dresden
Collaborators: University of Leipzig, University Hospital Dresden

This content was sourced from clinicaltrials.gov