NCT06803420

Brief Summary

This study aims to test a new AI-powered portable MRI scanner that can quickly identify whether a brain scan is normal or abnormal. Currently, standard MRI scans are expensive and have long waiting times. Our goal is to see if a smaller, cheaper, and more accessible MRI scanner-combined with artificial intelligence (AI)-can help doctors identify abnormalities faster and improve patient care. We will invite patients from King's College Hospital (KCH) who are already having a standard MRI scan. They will be asked to have an extra scan using the portable MRI, which takes about 60 minutes. The AI tool will then analyse these scans and compare its results to those of expert radiologists. By the end of the study, we hope to prove whether portable MRI with AI can be used in hospitals and GP clinics, making brain scans more accessible, reducing wait times, and helping doctors prioritise urgent cases. This study is funded by the Medical Research Council (MRC) and has been approved by UK research ethics committees.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Feb 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Feb 2025Oct 2027

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Head Injury

Outcome Measures

Primary Outcomes (1)

  • Accuracy of AI toll for triaging scans as "normal or "abnormal"

    Ai Triage accuracy compared with consultant neuroradiologists assessment.

    36 months

Secondary Outcomes (3)

  • Generalisability of AI tool (evaluated on external dataset).

    36 months

  • Patient acceptability of portable MRI (survey/interviews)

    36 months

  • Feasibility of integrating portable MRI in clinical pathways.

    36 months

Study Arms (1)

Portable, ultra-low-field MRI scanner

EXPERIMENTAL

Patients undergoing a standard brain MRI scan will be invited to have an additional portable MRI scan within 30 days of their clinical scan.

Device: Portable, ultra-low-field MRI scanner

Interventions

Portable, ultra-low-field MRI scannerDEVICE

This study evaluates a portable, ultra-low-field MRI scanner (the Hyperfine Swoop) combined with artificial intelligence (AI) to detect brain abnormalities. Patients undergoing a standard brain MRI scan will be invited to have an additional portable MRI scan within 30 days of their clinical scan. The portable MRI scan will take approximately 60 minutes, using multiple imaging sequences, including T2-weighted scans. The AI system will then analyse the portable MRI images and categorise them as "normal" or "abnormal". The results will be compared with expert neuroradiologist reports from standard MRI scans to validate accuracy. This intervention aims to assess whether portable MRI with AI can provide a low-cost, accessible alternative to standard MRI, potentially improving triage and reducing waiting times for patients requiring urgent brain imaging.

Portable, ultra-low-field MRI scanner

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years old. Undergoing standard brain MRI including T2-weighted sequences.

You may not qualify if:

  • Contraindications to MRI (e.g. pacemaker, pregnancy). Poor quality MRI scans without a neuroradiology report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Thomas Booth, Dr

    King's College London & King's College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frantisek Vasa, PhD

CONTACT

020 7848 9670Frantisek.Vasa@kcl.ac.uk

Giusi Manfredi, PhD

CONTACT

020 7848 9670giusi.manfredi@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share