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Assessment of Liver Diseases Using a Deep-Learning Approach Based on Ultrasound RF-Data

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Trial details

Who runs it
Technische Universität Dresden
Trial code
NCT06317181
Record updated
20 August 2025
Original description
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.Read full original descriptionShow less

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

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

Inclusion: scheduled for an ultrasound investigation by an independent physician; signed declaration of consent.

Exclusion: major intervention at the liver (for example partial resection); smaller interventions in the same liver during the last 2 Week (for example liver biopsy); contrast enhanced ultrasound less than a day ago.

ClinicalTrials.gov NCT06317181