Artificial Intelligence-Assisted Magnetic Resonance Imaging for Quality, Efficiency and Equity in the National Health Service (NHS) Care of Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI software.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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.
Primary outcome measures
- To assess the clinical usefulness of icobrain ms by evaluating the detection of disease activity (as defined by new/expanding lesions). [Time frame: From enrollment to the end of treatment at 12 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Barts Health NHS Trust — London
Identifiers
NCT: NCT07111637 · Worktribe 8529379 · AI_AWARD02608