Assessment of Liver Diseases Using a Deep-Learning Approach Based on Ultrasound RF-Data
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of elastography data, Collection of ultrasonic raw data.
- Who it may be relevant to
- Registry conditions: Artificial Intelligence, Ultrasonography, Elasticity Imaging Techniques, Liver Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Device Collection of elastography data
patients who are scheduled for an elastography for clinical reasons usually receive an ultrasound scan in which the b-mode images of the liver tissue are collected. In this study additional radiofrequency data is collected through a software access. - Device Collection of ultrasonic raw data
Patients who are transferred to the ultrasound departement due to suspicious focal lesions receive an ultrasonic investigation including the acquisition of raw data and extracting a definitive diagnose from the following clinical routine investigation, depending on the standards of the participating center
Primary outcome measures
- Performance analysis of the trained model [Time frame: After study completion, estimated 1 year]
Eligibility criteria
Inclusion criteria
- scheduled for an ultrasound investigation by an independent physician
- signed declaration of consent
Exclusion criteria
- smaller interventions in the same liver during the last 2 Week (for example liver biopsy)
- contrast enhanced ultrasound less than a day ago
- major intervention at the liver (for example partial resection)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Germany · 4 centers
- University Hospital — Dresden
- Diakonissen Hospital Dresden — Dresden
- University Hospital Halle (Saale) — Halle
- University Hospital Leipzig — Leipzig
Identifiers
NCT: NCT06317181 · DifLivSPECTRUS