Movile medical imaging devices are invaluable for clinical diagnostic purposes both inside and outside healthcare institutions. Unfortunately, Magnetic Resonance Imaging (MRI), the gold standard for numerous neurological and musculoskeletal conditions, is not readily portable. Recently, low-field MRI companies have demonstrated the first decisive steps towards portability within medical facilities and vehicles, but the scanners’ weight and dimensions are still incompatible with more demanding use cases such as in remote and developing regions, sports facilities and events, and medical or home healthcare.

In a collaboration between CSIC, PHYS and LA FE, we have recently demonstrated in the Histo-MRI and PR Scanner projects in vivo images taken with a light, small footprint, low-field extremity MRI scanner outside the controlled settings provided by medical facilities, opening a path towards highly accessible MRI under circumstances previously unrealistic. To this end, we acquired images of a volunteer’s knee in indoor and outdoor environments, including the first-ever MRI images obtained at a patient’s home, and even in open air connected to a gasoline generator. In 2022, we installed the scanner in the medical facilities of the Ricardo Tormo Motor Racing Circuit during the four days of the Motorcycle Grand Prix held in Valencia (Spain), whose medical staff were able to visualize a number of lesions and conditions, including a traumatic arthritis which an X-ray radiograph and visual inspection had missed.

Goals

In this project we will take the necessary technical, industrial and entrepreneurial steps to tackle the massive deployment of low-field portable systems for point-of-care and bedside imaging in clinics large and small, home and hospice care, rural areas, sports facilities and events, making MRI available to a large fraction of the world population with no or insufficient access. To advance towards this highly ambitious goal, the objectives of the NextMRI project include:

1. expanding the current technology to both extremity and brain imaging
2. improving the diagnostic capabilities with machine learning
3. improving the portability and usability to meet end-user needs
4. optimizing production costs
5. gathering medical evidence of the technology performance with clinical trials
6. developing a sustainable business case and model towards commercialisation

State of the Art

The most relevant milestone demonstrating the feasibility of NextMRI is the first-generation scanner. The resulting images show sufficient tissue contrast and spatial resolution to identify relevant anatomical features, including muscles, fat, cortical bone, bone marrow, tendons, ligaments, veins, arteries and fascia. Besides, we also show different contrast mechanisms, with weightings on T1, T2 and proton density. Professional radiologists at LA FE (Spain) confirm that the acquired images contain sufficient anatomical information to diagnose a large variety of articular diseases, including effusion, synovial engorgement, tendon disruption or bone fractures, within acceptable scan times. Furthermore, the portable scanner has been shown to operate successfully in three highly unconventional scenarios: an office room, in open air, and inside a patient’s living room. We have also acquired images from a volunteer diagnosed with lateral gonarthrosis due to cartilage damage in their right knee, and carrying a fixation metallic implant screwed to the femur. This appears sharp in our low-field acquisitions, but leads to high intensity artifacts around the metallic hardware in high-field MR images due to incorrect spin mapping. In 2022, we installed our scanner in the Motorcycle Grand Prix held in Valencia (Spain), where we scanned 14 subjects, running a total of 21 protocols for wrist, knee and ankle imaging. Out of eight scans on previously diagnosed lesions, only two (a meniscus tear and a Baker cyst) were not detected by the experts that evaluated our images. Notably, a subject reporting pain in a wrist revealed a traumatic arthritis which an X-ray radiograph and visual inspection had missed.

METHODOLOGY

Our ultimate goal is to site NextMRI scanners in clinics worldwide. We consider 3 phases: PHASE 1 Prototype design and development, based on the Histo-MRI results and current advancements of the PR SCANNER project (Nov 23 – Apr 25), and on the information gathered from clinicians and the relevant stakeholders; PHASE 2 Technical and usability validation of the system in lab and relevant environments (Sep 25 – Sep 26); PHASE 3 Assess market acceptance solutions and develop the BP to reach new investors (until Dec 26).

The project will develop a Human Factors Plan, relying on User Centred Design (UCD). This approach involves end-users (different profiles of clinicians, management, patients, maintenance) and remaining stakeholders (institutions, purchase managers, etc.) in a Lean process during the entire product development. This process will follow the guidelines for CE marking, defined in the Medical Devices Regulation (MDR), to facilitate a future labelling.

Consortium

The team that composes the NextMRI consortium has been carefully designed to cover all the aspects that will arise in the project, with a balance between technical (CSIC, LUMC), clinical (LA FE, BERG) and business (PHYS) partners. Still, there is great interplay among partners in the majority of tasks. The involvement of the clinical partners goes beyond the mere trials, as both have extensive experience in research projects.

• CSIC (Spain) will be coordinator due to its experience and involvement in previous steps of the scanner development (Histo-MRI and PR SCANNER projects). CSIC will also be key to the technical development of the scanner as it works on novel instrumentation and software algorithms in the area of medical imaging.
• PHYS (Spain) is a company created in 2021 that emerges from the Histo-MRI project. PHYS will take the steps needed at this stage to successfully bring the scanner to the market in the future, with a skilled and experienced core team.
• LUMC (Netherlands) develops new MRI hardware, pulse sequences and reconstruction methodologies for clinical research, and it also performs fundamental and applied research in the area of biomedical image processing and analysis. Its contribution will be crucial in the development of ML algorithms for image reconstruction and diagnosis.
• LA FE (Spain) is a Centre of Clinical and Research Excellence with its own research group, the Biomedical Imaging Research Group that belongs to the International Network of Biomedical Research in Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), recently recognised as a node of the RedIB (Distributed Network of Biomedical Imaging) within the Singular Technical Scientific Infrastructures (ICTS) program of the Government of Spain.
• BERG (Germany) has recently started to further expand their network of focus clinics for plannable medical care in the country. Two of their specialties are orthopaedic care and plastic surgery, both potential niches of application for NextMRI. Their experience on every stage of clinical trials, from methodology planning to data analysis, will be invaluable for the preliminary tests forecasted in the project.