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

NCT ID: NCT06317181

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Elastography

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

Group Type: EXPERIMENTAL

Collection of elastography data

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Collection of ultrasonic raw data

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Dresden

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Moritz Herzog

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moritz Herzog, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dresden

Locations

University Hospital

Dresden, , Germany

Site Status: RECRUITING

Diakonissen Hospital Dresden

Dresden, , Germany

Site Status: RECRUITING

University Hospital Halle (Saale)

Halle, , Germany

Site Status: RECRUITING

University Hospital Leipzig

Leipzig, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Moritz Herzog, MD

Role: CONTACT

moritz.herzog@ukdd.de

0049 351 458 11501

Facility Contacts

Moritz Herzog, MD

Role: primary

moritz.herzog@ukdd.de

0049 15785617350

Matthias Ziesch, MD

Role: primary

Matthias.Ziesch@diako-dresden.de

Valentin Blank, MD

Role: primary

Valentin.Blank@uk-halle.de

Thomas Karlas, MD

Role: primary

Thomas.Karlas@medizin.uni-leipzig.de

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://digitalhealth.tu-dresden.de/projects/hybridecho/spectrus/

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

Other Identifiers

DifLivSPECTRUS

Identifier Type: -

Identifier Source: org_study_id