跳至主要内容
临床试验/NCT06841887
NCT06841887招募中不适用

Unlock the Power of Resona 9 Ultrasound Machine: an Observational Study to Set-up and Test New Advanced Vascular Imaging Protocols

Mario Negri Institute for Pharmacological Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Non-dominant arm US acquisitions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Non-dominant arm US acquisitions

时间窗: 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

时间窗: US acquisition at enrollment

Time averaged velocity (TAV) of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (cm/s)

次要结局

未报告次要终点

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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