New Advanced Vascular Imaging Ultrasound Protocols (RESONA-SETTING)

August 28, 2025 updated by: Mario Negri Institute for Pharmacological Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • BG
      • Ranica, BG, Italy, 24020
        • Recruiting
        • Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Males, age group 1
Male subjects aged 18-40 years
Diagnostic test: US acquisitions
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
Males, age group 2
Male subjects aged 41-55 years
Diagnostic test: US acquisitions
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
Males, age group 3
Male subjects aged 56-75 years
Diagnostic test: US acquisitions
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
Female, age group 1
Female subjects aged 18-40 years
Diagnostic test: US acquisitions
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
Females, age group 2
Female subjects aged 41-55 years
Diagnostic test: US acquisitions
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
Females, age group 3
Female subjects aged 56-75 years
Diagnostic test: US acquisitions
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
US acquisition at enrollment
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)
US acquisition at enrollment
Non-dominant arm US acquisitions
Time Frame: US acquisition at enrollment
Thickness of the radial artery and cephalic vein wall (mm)
US acquisition at enrollment
Non-dominant arm US acquisitions
Time Frame: US acquisition at enrollment
Stiffness of the radial artery and cephalic vein wall (%)
US acquisition at enrollment
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)
US acquisition at enrollment
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)
US acquisition at enrollment
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)
US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Time Frame: US acquisition at enrollment
Thickness of the wall of the common carotid (mm)
US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Time Frame: US acquisition at enrollment
Stiffness of the wall of the common carotid (%)
US acquisition at enrollment
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)
US acquisition at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mario Negri Institute for Pharmacological Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Giuseppe Remuzzi, M.D., Istituto Di Ricerche Farmacologiche Mario Negri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RESONA-SETTING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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