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NCT Number: NCT07037966

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario y Politécnico la Fe

Valencia, 46026, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with suspected multiple sclerosis

Exclusion criteria

  • Any contradictions for high-field MRI

Treatment and study plan

MRI

Device

Standard 3T MRI Scan

Primary outcomes

  1. Radiological reports to Evaluate NextMRI prototype performance

    Time frame: 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:

    • Radiologists will report the high-resolution MR images in a structured report as part of their clinical duties.
    • 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
    • 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 outcomes

  1. Patient Comfort and Satisfaction Questionnaire to Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner

    Time frame: 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.

  2. User Comfort and Satisfaction Questionnaire Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Paula Doria Borrell, PhD

CONTACT

[email protected]

+34629301756

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Collaborators

  • National Research Council, Spain

Registry information

Official study title

Truly Portable MRI for Extremity and Brain Imaging Anywhere & Everywhere

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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