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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Performance analysis of the trained model
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Elastography
Collection of ultrasound data and elastography data from patients who were clinically planned for elastography
Intervention: Collection of elastography data (Device)
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.
Intervention: Collection of ultrasonic raw data (Device)
Outcomes
Primary Outcomes
Performance analysis of the trained model
Time Frame: After study completion, estimated 1 year
Analysis of the concordance of a Deep Learning-based analysis of RF data with established clinical measures. In case of diffuse disease the stiffness of the tissue and in case of the focal lesions the underlying disease as diagnosed by the local physicians are the measures. Performance is evaluated by the area under the receiver operating characteristic curve and a correlation coefficient.
Secondary Outcomes
No secondary outcomes reported
Investigators
Moritz Herzog
Principal Investigator
Technische Universität Dresden