Artificial Intelligence-Assisted Magnetic Resonance Imaging for Quality, Efficiency and Equity in the National Health Service (NHS) Care of Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-14

Study Completion Date

2026-04-14

Brief Summary

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Multiple Sclerosis (MS) is a long-term disease that affects over 150,000 people in the UK. Starting treatment early is important for managing Multiple Sclerosis (MS). It is also essential to monitor the treatment to see if it is working and to switch treatments if needed.

Magnetic resonance imaging (MRI) is the only accepted tool to monitor how well the treatment is working. Current evaluation of brain Magnetic resonance imaging (MRI) scans requires visual inspection, of which sensitivity is degraded by human, and technical factors, such as lack of time, fatigue of radiologists, and lack of standardization of image acquisition protocols across the National Health Service (NHS). MRI-readings can be significantly enhanced by artificial intelligence (AI)-assistive software. Evidence suggests the rate of new lesion detection to be 3 - 4 times higher when using assistive software compared to visual inspection of MRI scans.

In this study, an Artificial Intelligence (AI) software called "icobrain ms." developed by the company "icometrix" (Leuven, Belgium) is tested. This tool helps track MS by measuring changes in the brain using MRI scans. The AI can highlight problem areas and create reports that doctors can use to make better decisions about participants' treatment. The aim of the study is to prove that icobrain ms can be used to assist the neuro-radiologist with their visual assessment of MRI scans by a radiologist, and that it will help clinicians make more informed decisions about participants' current MS treatment.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiological reading by a neuroradiologist assisted by icobrain ms.

icobrain ms Artificial Intelligence (AI) assistive software

Group Type EXPERIMENTAL

AI software

Intervention Type DEVICE

icobrain ms is an Artificial Intelligence (AI)-assistive software which quantifies brain Magnetic Resonance Imaging (MRIs) and summarises clinically relevant findings for patients with Multiple Sclerosis in structured electronic radiological reports and annotated images.

Radiological reading by a neuroradiologist

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AI software

icobrain ms is an Artificial Intelligence (AI)-assistive software which quantifies brain Magnetic Resonance Imaging (MRIs) and summarises clinically relevant findings for patients with Multiple Sclerosis in structured electronic radiological reports and annotated images.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinically Isolated Syndrome suggestive of demyelination (CIS) or definitive diagnosis of MS.
* Undergoing MRI head investigation.
* On an MS DMT pathway.
* Access to a smartphone, tablet or computer.

Exclusion Criteria

* patients with Multiples Sclerosis participating in a randomised controlled CTIMP (participating in a single arm study may be included, provided this is in line with the other protocol).

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No