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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Ultrasonography; Artificial Intelligence; Elasticity Imaging Techniques; Metastasis to Liver
• Intervention / Treatment: Device: Collection of elastography data; Device: Collection of ultrasonic raw data

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moritz Herzog, MD; Phone Number: 0049 351 458 11501; Email: moritz.herzog@ukdd.de

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • University Hospital
    • Contact: Moritz Herzog, MD; Phone Number: 0049 15785617350; Email: moritz.herzog@ukdd.de
  • Dresden, Germany
    • Recruiting
    • Diakonissen Hospital Dresden
    • Contact: Matthias Ziesch, MD; Email: Matthias.Ziesch@diako-dresden.de
  • Halle (Saale), Germany
    • Recruiting
    • University Hospital Halle (Saale)
    • Contact: Valentin Blank, MD; Email: Valentin.Blank@uk-halle.de
  • Leipzig, Germany
    • Recruiting
    • University Hospital Leipzig
    • Contact: Thomas Karlas, MD; Email: Thomas.Karlas@medizin.uni-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elastography; Collection of ultrasound data and elastography data from patients who were clinically planned for elastography	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.
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance analysis of the trained model	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.	After study completion, estimated 1 year

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: University of Leipzig; University Hospital Dresden
• Investigators: Principal Investigator: Moritz Herzog, MD, University Hospital Dresden

Publications and helpful links

Helpful Links

• Webpage of the project with updated information, participating partners and resulting publications

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Quantitative Ultrasound; Radiofrequency Data
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: DifLivSPECTRUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the publication of data the anonymized IPD will be provided.
• IPD Sharing Time Frame: after finishing the study, data will be stored locally for at least 7 years
• IPD Sharing Access Criteria: contact the investigators via mail
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No