Truly Portable MRI for Extremity and Brain Imaging Anywhere & Everywhere
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Radiological reports to Evaluate NextMRI prototype performance
研究概览
简要总结
Mobile imaging diagnostic devices are extremely valuable for clinical diagnosis both inside and outside healthcare facilities. However, Magnetic Resonance Imaging (MRI)-the gold standard for diagnosing many neurological and musculoskeletal conditions-is not easily portable. Moreover, due to its high cost (in the million-euro range) and limited availability, the average wait time in Europe for an MRI scan is from several weeks to months.
The NextMRI project aims to take the technical, industrial, and commercial steps required to deploy portable low-field MRI systems in remote and developing regions, rural areas, sporting events, military or medical camps, and home healthcare settings, improving diagnostic capabilities. The specific goals of the NextMRI project are:
- Expand current low-field MRI technology to brain imaging.
- Enhance diagnostic accuracy using machine learning.
- Improve portability and usability for end users.
- Reduce production costs for broader affordability.
- Collect clinical evidence through trials to validate medical performance.
- Develop a sustainable business model for market commercialization.
详细描述
Based on this context, the NextMRI project will carry out a clinical evaluation study involving a multidisciplinary team of radiologists, rheumatologists, physiotherapists, data managers, and physicists. The study will focus on patients with suspected multiple sclerosis (MS). Its main goals are to:
- Assess the diagnostic value of the low-field MRI prototype.
- Evaluate usability for end users.
- Train AI algorithms using deep learning to differentiate between healthy and damaged tissues, thereby aiding radiologists, reducing diagnostic time, and lightening their workload.
Radiologists will first generate structured reports based on standard high-resolution MRI scans. They will then evaluate the low-field MRI images from the NextMRI prototype. The initial high-field MRI reports will serve as the reference standard for assessing performance and training the AI system.
Each patient will undergo two MRI scans on the same day (after providing informed consent): one at the standard 3T MR scan and other at the low-field MRI scan (NextMRI). To prevent bias, both scans will be interpreted by a professional radiologist with an 8-week interval between readings.
A total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be included. Patients with any contraindications for high-field MRI will be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The radiologist is assessing the diagnostic outcome without knowledge of the reference scan.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected multiple sclerosis
排除标准
- •Any contradictions for high-field MRI
研究组 & 干预措施
Patients with Suspected Multiple Sclerosis
A total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be scanned using both the 3T MRI and the NextMRI prototype.
干预措施: MRI (Device)
结局指标
主要结局
Radiological reports to Evaluate NextMRI prototype performance
时间窗: Through study completion, an average of 1 year
A clinical evaluation study will be performed involving a multidisciplinary team of radiologists, traumatologists, rheumatologists, physiotherapists, data managers and physicists. The validation strategy will be structured in 3 steps: 1. Radiologists will report the high-resolution MR images in a structured report as part of their clinical duties. 2. Radiologists will evaluate the MR images acquired with the PR Gen III scanner after 8 weeks, in order be blind to the first reading and avoid learning interobserver bias 3. Finally, the gold standard information obtained by the initial radiological report will serve to evaluate the prototype performance and train the Deep Learning tools. The report documents technical details, contrast use, and lesion analysis in brain, spine, and medulla. It quantifies key MS-related lesions, categorizes locations, and notes other abnormalities. A diagnostic impression summarizes findings to support MS diagnosis.
次要结局
- Patient Comfort and Satisfaction Questionnaire to Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner(1 year)
- User Comfort and Satisfaction Questionnaire Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner(1 year)