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

Technische Universität Dresden

Status: Enrolling

Conditions: Elasticity Imaging Techniques; Artificial Intelligence; Ultrasonography; Metastasis to Liver; Liver Diseases

Treatments: Device: Collection of ultrasonic raw data; Device: Collection of elastography data

Study type: Interventional

Funder types: Other

Identifiers

NCT06317181

DifLivSPECTRUS

Details and patient eligibility

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Elastography

Experimental group

Description:

Collection of ultrasound data and elastography data from patients who were clinically planned for elastography

Treatment:

Device: Collection of elastography data

Focal lesion

Experimental group

Description:

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.

Treatment:

Device: Collection of ultrasonic raw data