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

NCT07037966 | Not Yet Recruiting

• 1 other identifier: NextMRI Brain Validation
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Expand current low-field MRI technology to brain imaging.
2. 2.Enhance diagnostic accuracy using machine learning.
3. 3.Improve portability and usability for end users.
4. 4.Reduce production costs for broader affordability.
5. 5.Collect clinical evidence through trials to validate medical performance.
6. 6.Develop a sustainable business model for market commercialization.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; MRI; Brain Imaging

Outcome Measures

Primary Outcomes (1)

• Radiological reports to Evaluate NextMRI prototype performance

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

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

  1 year

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

  1 year

Study Arms (1)

Patients with Suspected Multiple Sclerosis

EXPERIMENTAL

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.

Device: MRI

Interventions

MRI DEVICE

Standard 3T MRI Scan

Patients with Suspected Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected multiple sclerosis

You may not qualify if:

• Any contradictions for high-field MRI

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• National Research Council, Spain: collaborator

Study Sites (1)

Hospital Universitario y Politécnico la Fe

Valencia, Valencia, 46026, Spain

Location

Related Publications (2)

• Guallart-Naval T, Algarin JM, Pellicer-Guridi R, Galve F, Vives-Gilabert Y, Bosch R, Pallas E, Gonzalez JM, Rigla JP, Martinez P, Lloris FJ, Borreguero J, Marcos-Perucho A, Negnevitsky V, Marti-Bonmati L, Rios A, Benlloch JM, Alonso J. Portable magnetic resonance imaging of patients indoors, outdoors and at home. Sci Rep. 2022 Jul 30;12(1):13147. doi: 10.1038/s41598-022-17472-w.

  PMID: 35907975 BACKGROUND

• O'Reilly T, Teeuwisse WM, de Gans D, Koolstra K, Webb AG. In vivo 3D brain and extremity MRI at 50 mT using a permanent magnet Halbach array. Magn Reson Med. 2021 Jan;85(1):495-505. doi: 10.1002/mrm.28396. Epub 2020 Jul 5.

  PMID: 32627235 BACKGROUND

Related Links

• Truly portable MRI for extremity and brain imaging anywhere \& everywhere

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Paula Doria Borrell, PhD

CONTACT

+34629301756; paula_doria@iislafe.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The radiologist is assessing the diagnostic outcome without knowledge of the reference scan.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)