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临床试验/NCT07111637
NCT07111637招募中不适用

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

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 1,336 人开始时间: 2025年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,336
试验地点
1
主要终点
To assess the clinical usefulness of icobrain ms by evaluating the detection of disease activity (as defined by new/expanding lesions).

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Radiological reading by a neuroradiologist assisted by icobrain ms.

Experimental

icobrain ms Artificial Intelligence (AI) assistive software

干预措施: AI software (Device)

Radiological reading by a neuroradiologist

No Intervention

Standard of Care

结局指标

主要结局

To assess the clinical usefulness of icobrain ms by evaluating the detection of disease activity (as defined by new/expanding lesions).

时间窗: From enrollment to the end of treatment at 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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