Renal DiseasesRESONA-SETTINGNCT06841887
New Advanced Vascular Imaging Ultrasound Protocols
An observational study of Renal Diseases and Cerebral Disorder, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
This is a single-center observational study aimed at setting up and testing new ultrasound vascular imaging protocols, conducted exclusively for research purposes. The study will perform US examinations in 60 subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Diseases, Cerebral Disorder
- What is being tested?
- US acquisitions
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2025to Mar 2027
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participation in this study will be proposed to subjects with no previous history of kidney or cerebral disease, and no pathologies that might have affected the vascular system (hypertension, diabetes). Sixty subjects will be studied, 30 females and 30 males. For both genders, they must be equally distributed within 3 age-groups: 18-40 years, 41-55 years and 56-75 years.
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Female and/or male aged between 18 and 75 years
- No previous history of kidney or cerebral disease and no pathologies that might have affected the vascular system
Who cannot join
- Previous history of kidney or cerebral disease or pathologies that might have affected the vascular system
- Legal incapacity, limited legal capacity, intellectual disability, uncooperative attitude or any other evidence that the subject will not be able to understand the study aims and procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
Ranica, BG, 24020
Matias Trillini, M.D., +39 035 4535 411, matias.trillini@marionegri.it
About this study
Official title: Unlock the Power of Resona 9 Ultrasound Machine: an Observational Study to Set-up and Test New Advanced Vascular Imaging Protocols
This is a single-center observational study aimed at setting up and testing new ultrasound vascular imaging protocols, conducted exclusively for research purposes. The study will perform US examinations in 60 subjects. The subjects enrolled in the study will be examined the first time and will then provide consent to be examined again in the future if needed.
The primary aim of this study is to set-up and test new advanced US protocol for the arm and cerebral blood vessels
Read more
The secondary objectives will be:
- Define ranges of normality/reference values of US-based parameters to be compared with pathological values.
- Evaluate the repeatability and reproducibility of the acquired US measurements.
- Evaluate the correlation between age and the acquired US measurements.
- Evaluate the correlation between gender and the acquired US measurements.
Read the detailed description
The Medical Imaging Laboratory of Istituto di Ricerche Farmacologiche Mario Negri IRCCS deals with the processing of diagnostic images, allowing quantitative analysis of anatomical structures and organs functions in vivo. The research activities of the group are focused on: i) developing novel techniques to segment and quantify anatomical structures and pathological lesions in response to specific clinical needs; ii) identifying and validating novel imaging biomarkers, iii) investigating novel morphologic and hemodynamic changes in different vascular districts and the role of hemodynamics in vascular disease onset and progression. Besides these activities, increasing efforts have recently been devoted to exploring the potential of novel imaging solutions and in setting up new non-invasive imaging protocols. These protocols have been primarily developed for the kidney and renal arteries, the cerebral vasculature, and the arteriovenous fistula used in hemodialysis, which are the main focus of the Medical Imaging Lab's activities. Specifically, in 2024 Istituto di Ricerche Farmacologiche Mario Negri IRCCS purchased the new ultrasound (US) machine Resona 9, within the ANTHEM project (ID: NCT05996731). Resona 9 is the top-of-the-line model among Mindray's ultrasound machines. It combines advanced features to deliver exceptional image quality with a suite of artificial intelligence-enhanced technologies designed to help clinicians improve reproducibility and optimize productivity. Specifically related to our research focus, the Resona 9 incorporates novel advanced functionalities to accurately measure vascular wall thickness and stiffness. Moreover, the VFlow technique enables the visualization of complex blood flow features. Our Resona 9 is also equipped with the PIUR tUS device, which transforms the US system into a tomographic 3D solution device. This allows the acquisition of a stack of images of the blood vessels and the reconstruction of 3D virtual models, with big advantages in terms of costs and velocity of the acquisition as compared to conventional magnetic resonance imaging.
To take full advantage of all these US-based techniques and make the most out of Resona 9 tools on patients with renal and cerebral pathologies, there is an urgent need of setting up dedicated US protocols and testing. This step will also allow collecting ranges of normality/reference values of image-based parameters, to be later used to compare with corresponding specific parameters acquired in patients.
- Conditions
- Renal Diseases, Cerebral Disorder
- Being tested
- US acquisitions
- Keywords
- ultrasound, imaging, vascular protocol
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US acquisitionsDiagnostic test
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
| Study group | Role | What they receive |
|---|---|---|
| Males, age group 1 | Male subjects aged 18-40 years Receives: Diagnostic Test: US acquisitions | |
| Males, age group 2 | Male subjects aged 41-55 years Receives: Diagnostic Test: US acquisitions | |
| Males, age group 3 | Male subjects aged 56-75 years Receives: Diagnostic Test: US acquisitions | |
| Female, age group 1 | Female subjects aged 18-40 years Receives: Diagnostic Test: US acquisitions | |
| Females, age group 2 | Female subjects aged 41-55 years Receives: Diagnostic Test: US acquisitions | |
| Females, age group 3 | Female subjects aged 56-75 years Receives: Diagnostic Test: US acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-dominant arm US acquisitions
Diameter of the radial artery in the middle forearm, brachial artery over the elbow, ulnar artery in the middle forearm and Cephalic vein in the middle forearm (mm)
Measured: US acquisition at enrollment
Non-dominant arm US acquisitions
Flow volume of the radial artery in the middle forearm, brachial artery over the elbow, ulnar artery in the middle forearm (ml/min)
Measured: US acquisition at enrollment
Non-dominant arm US acquisitions
Thickness of the radial artery and cephalic vein wall (mm)
Measured: US acquisition at enrollment
Non-dominant arm US acquisitions
Stiffness of the radial artery and cephalic vein wall (%)
Measured: US acquisition at enrollment
Non-dominant arm US acquisitions
Time averaged velocity (TAV) of the radial artery in the middle forearm, brachial artery over the elbow and ulnar artery in the middle forearm (cm/s)
Measured: US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Diameter of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (mm)
Measured: US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Flow volume of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (ml/min)
Measured: US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Thickness of the wall of the common carotid (mm)
Measured: US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Stiffness of the wall of the common carotid (%)
Measured: US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Time averaged velocity (TAV) of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (cm/s)
Measured: US acquisition at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start9 May 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseasesStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, M.D., Study director, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841887
- Sponsor's protocol ID
- RESONA-SETTING
- Acronym
- RESONA-SETTING
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unlock the Power of Resona 9 Ultrasound Machine: an Observational Study to Set-up and Test New Advanced Vascular Imaging Protocols
- ClinicalTrials.gov ID
- NCT06841887
- Acronym / sponsor ID
- RESONA-SETTING / RESONA-SETTING
- Conditions
- Renal Diseases, Cerebral Disorder
- Keywords
- ultrasound, imaging, vascular protocol
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Feb 2025 (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.
This is a single-center observational study aimed at setting up and testing new ultrasound vascular imaging protocols, conducted exclusively for research purposes. The study will perform US examinations in 60 subjects. The subjects enrolled in the study will be examined the first time and will then provide consent to be examined again in the future if needed.
The primary aim of this study is to set-up and test new advanced US protocol for the arm and cerebral blood vessels
The secondary objectives will be:
- Define ranges of normality/reference values of US-based parameters to be compared with pathological values.
- Evaluate the repeatability and reproducibility of the acquired US measurements.
- Evaluate the correlation between age and the acquired US measurements.
- Evaluate the correlation between gender and the acquired US measurements.
Detailed description
The Medical Imaging Laboratory of Istituto di Ricerche Farmacologiche Mario Negri IRCCS deals with the processing of diagnostic images, allowing quantitative analysis of anatomical structures and organs functions in vivo. The research activities of the group are focused on: i) developing novel techniques to segment and quantify anatomical structures and pathological lesions in response to specific clinical needs; ii) identifying and validating novel imaging biomarkers, iii) investigating novel morphologic and hemodynamic changes in different vascular districts and the role of hemodynamics in vascular disease onset and progression. Besides these activities, increasing efforts have recently been devoted to exploring the potential of novel imaging solutions and in setting up new non-invasive imaging protocols. These protocols have been primarily developed for the kidney and renal arteries, the cerebral vasculature, and the arteriovenous fistula used in hemodialysis, which are the main focus of the Medical Imaging Lab's activities. Specifically, in 2024 Istituto di Ricerche Farmacologiche Mario Negri IRCCS purchased the new ultrasound (US) machine Resona 9, within the ANTHEM project (ID: NCT05996731). Resona 9 is the top-of-the-line model among Mindray's ultrasound machines. It combines advanced features to deliver exceptional image quality with a suite of artificial intelligence-enhanced technologies designed to help clinicians improve reproducibility and optimize productivity. Specifically related to our research focus, the Resona 9 incorporates novel advanced functionalities to accurately measure vascular wall thickness and stiffness. Moreover, the VFlow technique enables the visualization of complex blood flow features. Our Resona 9 is also equipped with the PIUR tUS device, which transforms the US system into a tomographic 3D solution device. This allows the acquisition of a stack of images of the blood vessels and the reconstruction of 3D virtual models, with big advantages in terms of costs and velocity of the acquisition as compared to conventional magnetic resonance imaging.
To take full advantage of all these US-based techniques and make the most out of Resona 9 tools on patients with renal and cerebral pathologies, there is an urgent need of setting up dedicated US protocols and testing. This step will also allow collecting ranges of normality/reference values of image-based parameters, to be later used to compare with corresponding specific parameters acquired in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Males, age group 1 | – | Diagnostic Test: US acquisitionsMale subjects aged 18-40 years |
| Males, age group 2 | – | Diagnostic Test: US acquisitionsMale subjects aged 41-55 years |
| Males, age group 3 | – | Diagnostic Test: US acquisitionsMale subjects aged 56-75 years |
| Female, age group 1 | – | Diagnostic Test: US acquisitionsFemale subjects aged 18-40 years |
| Females, age group 2 | – | Diagnostic Test: US acquisitionsFemale subjects aged 41-55 years |
| Females, age group 3 | – | Diagnostic Test: US acquisitionsFemale subjects aged 56-75 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in this study will be proposed to subjects with no previous history of kidney or cerebral disease, and no pathologies that might have affected the vascular system (hypertension, diabetes). Sixty subjects will be studied, 30 females and 30 males. For both genders, they must be equally distributed within 3 age-groups: 18-40 years, 41-55 years and 56-75 years.
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- Female and/or male aged between 18 and 75 years
- No previous history of kidney or cerebral disease and no pathologies that might have affected the vascular system
Key exclusion criteria (2 listed)
- Previous history of kidney or cerebral disease or pathologies that might have affected the vascular system
- Legal incapacity, limited legal capacity, intellectual disability, uncooperative attitude or any other evidence that the subject will not be able to understand the study aims and procedures
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 |
|---|---|---|
| US acquisitionsUS acquisition from two anatomical regions i.e., the non-dominant arm and the neck. | Diagnostic test | Female, age group 1, Females, age group 2, Females, age group 3, Males, age group 1, Males, age group 2, Males, age group 3 |
Primary outcome
Non-dominant arm US acquisitions
Time frame: US acquisition at enrollment
Diameter of the radial artery in the middle forearm, brachial artery over the elbow, ulnar artery in the middle forearm and Cephalic vein in the middle forearm (mm)
Non-dominant arm US acquisitions
Time frame: US acquisition at enrollment
Flow volume of the radial artery in the middle forearm, brachial artery over the elbow, ulnar artery in the middle forearm (ml/min)
Non-dominant arm US acquisitions
Time frame: US acquisition at enrollment
Thickness of the radial artery and cephalic vein wall (mm)
Non-dominant arm US acquisitions
Time frame: US acquisition at enrollment
Stiffness of the radial artery and cephalic vein wall (%)
Non-dominant arm US acquisitions
Time frame: US acquisition at enrollment
Time averaged velocity (TAV) of the radial artery in the middle forearm, brachial artery over the elbow and ulnar artery in the middle forearm (cm/s)
Neck carotid (right and left) US acquisitions
Time frame: US acquisition at enrollment
Diameter of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (mm)
Neck carotid (right and left) US acquisitions
Time frame: US acquisition at enrollment
Flow volume of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (ml/min)
Neck carotid (right and left) US acquisitions
Time frame: US acquisition at enrollment
Thickness of the wall of the common carotid (mm)
Neck carotid (right and left) US acquisitions
Time frame: US acquisition at enrollment
Stiffness of the wall of the common carotid (%)
Neck carotid (right and left) US acquisitions
Time frame: US acquisition at enrollment
Time averaged velocity (TAV) of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (cm/s)
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 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Giuseppe Remuzzi, M.D. study director
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Diseases and Cerebral Disorder, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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 3 inclusion and 2 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Michela Bozzetto, Ph.D. (+39 035 4535 381, michela.bozzetto@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-dominant arm US acquisitions (time frame: US acquisition at enrollment). The study lists 10 primary outcomes in all. 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 5 Sep 2025.