Advancing Portable Brain Imaging: The NextMRI Project's Role in Revolutionizing Diagnostic MRI

Instituto de Investigacion Sanitaria La Fe

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Device: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT07037966

NextMRI Brain Validation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with suspected multiple sclerosis

Exclusion criteria

• Any contradictions for high-field MRI

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Patients with Suspected Multiple Sclerosis

Experimental group

Description:

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.

Treatment:

Device: MRI

Device: MRI