To test artificial intelligence (AI)-assisted magnetic resonance imaging (MRI) in detecting disease activity in Multiple Sclerosis, and to determine whether AI impacts MRI review, treatment decisions, costs, and follow-up care

Plain English summary of protocol

Background and study aims
Multiple sclerosis (MS) is a chronic, disabling disease driven by an abnormal immune response to the central nervous system. Over 120,000 people live with MS in the UK costing the NHS more than £1billion/year. Early disease modifying treatment (DMT) is part of the standard of care for people with MS (pwMS). Unless effectively treated, MS leads to significant disability, and in most cases associated care costs. However, whether any of the currently licensed fifteen DMTs is effective in an individual person with MS is unpredictable. Effective treatment monitoring is essential to (i) detect signs of disease activity before the individual suffers its effects and (ii) enable early switching to a different, hopefully (more) effective, DMT. In clinical practice, regular magnetic resonance imaging (MRI) is the only established tool for DMT efficacy monitoring. However, detecting the often-subtle changes by inspecting MRI scans is time consuming, tiring and therefore error-prone. Icobrain-ms is a validated AI technology enabling quantification of MRI datasets, summarising findings in a structured electronic report as well as annotated images highlighting areas of change that help guide assessment. Icobrain-ms complements visual assessment of MRI scans and helps the clinician to decide whether a change in DMT is warranted.

Who can participate?
Patients age over 18 with Clinically Isolated Syndrome suggestive of demyelination (CIS) or definitive diagnosis of MS will be recruited from the neuro-inflammation services of the participating clinical trial sites. They must also be either on a DMT or under consideration for DMT. Potential participants will be identified by the Principal Investigator (PI) and other members of the clinical care teams from the caseload of patients under the care of each site’s hospital or Trust. These will be patients that are due their MRI brain scans as per standard of care. The single exclusion criterion is patient with MS participating in a randomised controlled CTIMP. Due to the severity of the disease, some participants may have some degree of cognitive impairment and may be considered as vulnerable participants as per the NHS England safeguarding guidelines. Whilst vulnerable participants will be included in this study, all participants, including those who are vulnerable, must have capacity.

What does the study involve?
Patients from 3 hospitals in the UK will be approached to take part in the study. 1336 participants will take part. The clinical usefulness of icobrain ms software will be assessed by evaluating the detection of disease activity (as defined by new/expanding lesions): what proportion of patients have disease activity detected when icobrain ms is being employed, alongside the visual assessment, compared to SoC assessment by a (neuro)radiologist.
The primary outcome is to identify difference in disease activity between the interventional arm and SoC based on baseline-year 1 and/or, where available, retrospective-baseline. We will also investigate:
- The clinical usefulness of icobrain ms.
- The contribution of icobrain ms to treatment initiation or switch decisions.
- The impact of icobrain ms on patient outcomes.
- The efficiency of radiologists reporting MRI scans.
- The cost-effectiveness of icobrain ms

All the elements of the patients’ treatment will follow the normal care pathway for all MS patients at the hospital.

What are the possible benefits and risks of participating?
Icobrain ms is a medical device intended for automatic labelling, visualisation and quantification of brain structures from a set of MRI images. The icobrain ms software will not be making independent ‘decisions’ on behalf of patient care, as expert neuro-radiologists will be involved with every scan interpretation. Therefore, there are no direct risks and harms associated with using icobrain ms and the device itself has no direct impact on the patient.

The possible benefits are:
1. The optimization and standardisation of brain scans acquisitions.
2. High accuracy and reliability: icobrain ms delivers accurate quantitative measurements of brain lesions and brain atrophy to monitor clinical changes.
3. Increased consistency of radiology report: icobrain ms creates more structured radiology reports increasing reader consistency for greater reliability of imaging results.
4. Reduced Health inequalities: icobrain ms can help to reduce health inequalities that are due to variation in MS expertise and sub-specialisation across the NHS.
5. Improve patient outcomes and reduce total cost of care: icobrain ms provides clinicians with valuable insights on disease activity, accelerating time to optimal treatment, which can improve patient outcomes and a reduction of health and other care costs associated with neurological disability.
 
Where is the study run from?
Queen Mary University of London (UK)

When is the study starting and how long is it expected to run for?
May 2022 to April 2027

Who is funding the study?
Department of Health and Social Care (UK)

Who is the main contact?
Prof Klaus Schmierer, assistms@qmul.ac.uk

Contact information

Prof Klaus Schmierer
Public, Scientific, Principal investigator

The Blizard Institute, Centre for Neuroscience, Surgery & Trauma
4 Newark Street
London
E1 2AT
United Kingdom

ORCID ID	0000-0002-9293-8893
Phone	+44 20 7882 6246
Email	k.schmierer@qmul.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Editorial Notes

24/02/2025: Trial's existence confirmed by London - Dulwich Research Ethics Committee.