New Advanced Vascular Imaging Ultrasound Protocols (RESONA-SETTING)

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: Recruiting
• Conditions: Renal Diseases; Cerebral Disorder
• Intervention / Treatment: Diagnostic test: US acquisitions

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: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Michela Bozzetto, Ph.D.; Phone Number: +39 035 4535 381; Email: michela.bozzetto@marionegri.it
• Study Contact Backup: Name: Luca Soliveri; Phone Number: +39 035 4535 381; Email: luca.soliveri@marionegri.it

Study Locations

• Italy
  • BG
    • Ranica, BG, Italy, 24020
      • Recruiting
      • Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
      • Contact: Matias Trillini, M.D.; Phone Number: +39 035 4535 411; Email: matias.trillini@marionegri.it

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	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)	US acquisition at enrollment
Non-dominant arm US acquisitions	Thickness of the radial artery and cephalic vein wall (mm)	US acquisition at enrollment
Non-dominant arm US acquisitions	Stiffness of the radial artery and cephalic vein wall (%)	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)	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)	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)	US acquisition at enrollment
Neck carotid (right and left) US acquisitions	Thickness of the wall of the common carotid (mm)	US acquisition at enrollment
Neck carotid (right and left) US acquisitions	Stiffness of the wall of the common carotid (%)	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)	US acquisition at enrollment

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Investigators: Study Director: Giuseppe Remuzzi, M.D., Istituto Di Ricerche Farmacologiche Mario Negri

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: imaging; ultrasound; vascular protocol
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases
• Other Study ID 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