Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06317181

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

Led by Technische Universität Dresden · Updated on 2025-08-20

200

Participants Needed

4

Research Sites

87 weeks

Total Duration

On this page

Sponsors

T

Technische Universität Dresden

Lead Sponsor

U

University Hospital Dresden

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for an ultrasound investigation by an independent physician
  • Signed declaration of consent
Not Eligible

You will not qualify if you...

  • Minor liver interventions within the last 2 weeks (e.g., liver biopsy)
  • Contrast-enhanced ultrasound performed less than one day ago
  • Major liver interventions such as partial liver resection

AI-Screening

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Trial Site Locations

Total: 4 locations

1

University Hospital

Dresden, Germany, 01307

Actively Recruiting

2

Diakonissen Hospital Dresden

Dresden, Germany

Actively Recruiting

3

University Hospital Halle (Saale)

Halle, Germany

Actively Recruiting

4

University Hospital Leipzig

Leipzig, Germany

Actively Recruiting

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Research Team

M

Moritz Herzog, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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