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

NCT06317181 | Recruiting

• 1 other identifier: DifLivSPECTRUS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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

Keywords

Quantitative Ultrasound; Radiofrequency Data

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Elastography

EXPERIMENTAL

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

Device: Collection of elastography data

Focal lesion

EXPERIMENTAL

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

Interventions

Collection of elastography data 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.

Elastography

Collection of ultrasonic raw data 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

Focal lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for an ultrasound investigation by an independent physician
• signed declaration of consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technische Universität Dresden: lead
• University Hospital Dresden: collaborator
• University of Leipzig: collaborator

Study Sites (4)

University Hospital

Dresden, 01307, Germany

RECRUITING

Diakonissen Hospital Dresden

Dresden, Germany

RECRUITING

University Hospital Halle (Saale)

Halle, Germany

RECRUITING

University Hospital Leipzig

Leipzig, Germany

RECRUITING

Related Links

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

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Moritz Herzog, MD

  University Hospital Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moritz Herzog, MD

CONTACT

0049 351 458 11501; moritz.herzog@ukdd.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Data is collected in a defined group of patients (all patients listed for elastography or for ultrasonic investigation due to a focal lesion in participating departments). Afterwards performances of algorithms are compared based on this group.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after finishing the study, data will be stored locally for at least 7 years
• Access Criteria: contact the investigators via mail

Locations

DE (4)