Artificial IntelligenceLivSPECTRUSNCT06317181
Assessment of Liver Diseases Using a Deep-Learning Approach Based on Ultrasound RF-Data
A study testing Collection of elastography data and Collection of ultrasonic raw data in people with Artificial Intelligence and Ultrasonography, run by Technische Universität Dresden at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence, Ultrasonography, Elasticity Imaging Techniques
- What is being tested?
- Collection of elastography data and Collection of ultrasonic raw data
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled for an ultrasound investigation by an independent physician
- signed declaration of consent
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
University Hospital
Dresden, 01307
Moritz Herzog, MD, 0049 15785617350, moritz.herzog@ukdd.de
- Recruiting
Diakonissen Hospital Dresden
Dresden
Matthias Ziesch, MD, Matthias.Ziesch@diako-dresden.de
- Recruiting
University Hospital Halle (Saale)
Halle
Valentin Blank, MD, Valentin.Blank@uk-halle.de
- Recruiting
University Hospital Leipzig
Leipzig
Thomas Karlas, MD, Thomas.Karlas@medizin.uni-leipzig.de
About this study
Official title: 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:
Read more
- 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
- Being tested
- Collection of elastography data, Collection of ultrasonic raw data
- Keywords
- Quantitative Ultrasound, Radiofrequency Data
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of elastography dataDevice
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.
Collection of ultrasonic raw dataDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Elastography | Experimental | Collection of ultrasound data and elastography data from patients who were clinically planned for elastography Receives: 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. Receives: Device: Collection of ultrasonic raw data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After study completion, estimated 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Apr 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Dresden, University of Leipzig
- Responsible party
- Principal investigator, Moritz Herzog, Technische Universität Dresden
- Investigators
- Moritz Herzog, MD, Principal investigator, University Hospital Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317181
- Sponsor's protocol ID
- DifLivSPECTRUS
- Acronym
- LivSPECTRUS
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of data the anonymized IPD will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06317181
- Acronym / sponsor ID
- LivSPECTRUS / DifLivSPECTRUS
- Conditions
- Artificial Intelligence, Ultrasonography, Elasticity Imaging Techniques, Liver Diseases, Metastasis to Liver
- Keywords
- Quantitative Ultrasound, Radiofrequency Data
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- University Hospital Dresden, University of Leipzig
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Elastography | Experimental | Device: Collection of elastography dataCollection of ultrasound data and elastography data from patients who were clinically planned for elastography |
| Focal lesion | Experimental | Device: Collection of ultrasonic raw dataCollection 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for an ultrasound investigation by an independent physician
- signed declaration of consent
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of elastography datapatients 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. | Device | Elastography |
| Collection of ultrasonic raw dataPatients 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 | Device | Focal lesion |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Webpage of the project with updated information, participating partners and resulting publicationsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the publication of data the anonymized IPD will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moritz Herzog, MD principal investigator
University Hospital Dresden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of elastography data and Collection of ultrasonic raw data in people with Artificial Intelligence and Ultrasonography, run by Technische Universität Dresden at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moritz Herzog, MD (0049 351 458 11501, moritz.herzog@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance analysis of the trained model (time frame: After study completion, estimated 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.