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Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study
Sponsor: icometrix
Summary
The goal of the PROCLAIM study is to assess the effectiveness of quantitative brain MRI, as measured by icobrain mr, on the detection of disease activity in multiple sclerosis, including the identification of smouldering disease, and the downstream effects on clinical decision making and patient outcomes in a real-world setting. The study will compare an intervention arm implementing quantitative brain MRI (using the CE-marked medical device software icobrain mr) as part of Standard of Care, and a control arm implementing Standard of Care without quantitative brain MRI.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2025-10-09
Completion Date
2028-11-30
Last Updated
2025-12-09
Healthy Volunteers
No
Interventions
quantitative brain MRI (icobrain mr)
Quantitative brain MRI refers to using a specialised software to compute volumes of brain structures and of MS lesions from brain MRI scans, and to measures differences between a previous brain MRI scan and the current brain MRI scan. The quantitative brain MRI solution being investigated in the PROCLAIM study is icobrain mr, a software solution that uses artificial intelligence (AI) to help with tracking of MS disease progression by measuring brain structures and lesions on magnetic resonance imaging (MRI).
Standard of Care (SOC)
Standard of Care practices at each participating site for management of multiple sclerosis.
Locations (6)
General University Hospital Prague
Prague, Prague, Czechia
Katholisches Klinikum Bochum - St. Joseph-Hospital
Bochum, North Rhine-Westphalia, Germany
Technische Universität Dresden
Dresden, Saxony, Germany
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
ASST Papa Giovanni XXIII Bergamo
Bergamo, Italy
Casa di Cura Igea
Milan, Italy