Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, MRI, Brain Imaging
Brief summary
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: 1. Expand current low-field MRI technology to brain imaging. 2. Enhance diagnostic accuracy using machine learning. 3. Improve portability and usability for end users. 4. Reduce production costs for broader affordability. 5. Collect clinical evidence through trials to validate medical performance. 6. Develop a sustainable business model for market commercialization.
Detailed description
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: 1. Assess the diagnostic value of the low-field MRI prototype. 2. Evaluate usability for end users. 3. 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.
Interventions
DEVICEMRI
Standard 3T MRI Scan
Sponsors
Instituto de Investigacion Sanitaria La Fe
National Research Council, Spain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The radiologist is assessing the diagnostic outcome without knowledge of the reference scan.
Intervention model description
All participants receive the same intervention. There's no randomization.-the aim is to evaluate the performance of the device within the same group of patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with suspected multiple sclerosis
Exclusion criteria
* Any contradictions for high-field MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological reports to Evaluate NextMRI prototype performance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort and Satisfaction Questionnaire to Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner | 1 year | Patients provide insights into their experiences with both scanners, focusing on aspects such as ease of entry and exit, comfort during positioning, perception of claustrophobia, noise levels, and overall satisfaction. Additionally, they compare the two scanners directly, offering valuable perspectives on which device they prefer and why. Their comments highlight subjective comfort and practical challenges, which are critical for improving patient-centered design. The Questionnaire will use a Likert scale (e.g., from 1 = very uncomfortable to 5 = very comfortable) combined with open-ended questions for additional comments. |
| User Comfort and Satisfaction Questionnaire Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner | 1 year | Healthcare professionals, including radiologists and MRI technicians, evaluate the scanners from an operational standpoint. Their feedback covers ease of use, image quality, workflow efficiency, technical issues, and overall satisfaction with the device's performance. They also compare the NextMRI prototype to the standard scanner, assessing its potential impact on clinical practice, particularly for patients with conditions like Multiple Sclerosis. Professionals are asked to identify any anticipated challenges in implementation and to suggest additional training or resources needed for optimal use. The Questionnaire will use a Likert scale (e.g., from 1 = very uncomfortable to 5 = very comfortable) combined with open-ended questions for additional comments. |
Countries
Spain
Contacts
CONTACTPaula Doria Borrell, PhD
Outcome results
None listed