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Truly Portable MRI for Extremity and Brain Imaging Anywhere & Everywhere
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario y Politécnico la Fe
Valencia, Valencia, Spain
Start Date
October 1, 2025
Primary Completion Date
September 1, 2026
Completion Date
September 1, 2026
Last Updated
September 23, 2025
50
ESTIMATED participants
MRI
DEVICE
MRI
DEVICE
Lead Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
NCT07225504
NCT06276634
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809192