Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study (PROCLAIM)

icometrix

Status: Begins enrollment in 1 month

Conditions: Multiple Sclerosis; Radiologically Isolated Syndrome; Clinically Isolated Syndrome

Treatments: Device: quantitative brain MRI (icobrain mr); Other: Standard of Care (SOC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07032246

ICO-S-003

Details and patient eligibility

About

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.

Full description

PROCLAIM (Clinical Impact through AI-assisted MS care: a prospective multi-centre study) is a prospective multi-country multi-site comparative effectiveness study conducted within the scope of the EU-funded research project "Clinical impact through AI-assisted MS Care" (CLAIMS). Quantitative brain MRI will be implemented in this study based on the icobrain mr medical device. icobrain mr is an AI software solution for brain MRI analysis in multiple sclerosis that provides quantitative measurements on disease activity and progression. icobrain mr is CE-marked as a medical device software Class IIa and will be used in PROCLAIM according to its intended use. The study does not involve procedures additional to those performed under the normal conditions of use of the device, nor any other invasive or burdensome procedures.

The study will assess the impact of using quantitative brain MRI, as measured by icobrain mr, on the quality of care. In particular, the study will evaluate the impact on detecting disease activity in MS, as well as on clinical decision-making and clinical outcomes in routine clinical practice for people with MS (pwMS). The study will target both the inflammatory and smouldering components of the disease using assessments already used in daily clinical routine. Exploratory analyses will focus on the relation to other biomarkers used in clinical routine of the participating sites (optic coherence tomography (OCT), evoked potentials (EPs)), as well as patient reported outcomes and passive monitoring measurements (sleep duration, step count and environmental temperature) collected via the icompanion patient app, in conjunction with clinical and radiological parameters.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to independently understand, evaluate and sign the informed consent form.
• Able to comply with the study protocol, including having a mobile device capable of running the icompanion app.
• Have a definite diagnosis of MS, confirmed as per revised McDonald 2017 criteria (treated or untreated) and/or a diagnosis of RIS/CIS (following the revised McDonald criteria presented during ECTRIMS 2024)
• Patients early in the disease course of RRMS (CIS/RIS, RRMS with disease duration < 7 years), patients with initial diagnosis of relapsing MS and disease duration 12-18 years (prone to convert to SPMS).
• Clinical and brain MRI data available at least one year prior to the study
• Age >= 18 years

Exclusion criteria

• Unable or unwilling to understand, evaluate and sign the informed consent form.
• Any contraindications for undergoing an MRI.
• Currently involved in another interventional study.
• Currently pregnant or planning a pregnancy in the coming 2 years.
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the study.
• Retrospective MRI not meeting requirements: at least, 3D T1-weighted images and fluid-attenuated inversion recovery (FLAIR) images (3D, or 2D with maximal slice thickness of 3mm).
• Patients with confirmed diagnosis of PPMS.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Standard of Care practices at each participating site will be employed. Participants in the control arm will receive care according to the usual procedures of the site, without icobrain mr analysis being provided to the participating site during the main study period.

Treatment:

Other: Standard of Care (SOC)

Standard of Care with quantitative brain MRI (icobrain mr)

Experimental group

Description:

Participants in the intervention arm will receive care according to the usual procedures of the participating sites and will have their brain MRI scans analysed using the icobrain mr software. icobrain mr results for each participant will be provided to the participating site prior to the regular clinic visit during the study period.

Treatment:

Other: Standard of Care (SOC)

Device: quantitative brain MRI (icobrain mr)