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

N/AEnrolling By InvitationNCT07032246

icometrix750 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

quantitative brain MRI (icobrain mr)DEVICE

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)OTHER

Standard of Care practices at each participating site for management of multiple sclerosis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Impact of using icobrain mr on detecting (inflammatory or smouldering) disease activity

The difference between control arm and interventional arm in the proportion of patients for whom disease activity or progression is reported by the neurologist at baseline.

Time frame: baseline

Impact of using icobrain mr on the clinical outcome

The difference between control arm and interventional arm in the number of patients with no disease activity or progression at month 24.

Time frame: month 24

Secondary Outcomes

Proportion of patients who switch treatment

Difference between control arm and interventional arm in the proportion of patients who switch their treatment due to detection of disease activity at baseline.

Time frame: baseline

Objective of each treatment switch

Descriptive analysis of the type and reason of treatment switches.

Time frame: baseline

Role of disease activity on MRI in the decision to make a treatment switch

Difference between control arm and interventional arm in the proportion of patients who switch their treatment due to disease activity on MRI.

Time frame: baseline

Role of quantitative brain MRI in the decision to make a treatment switch

Number of treatment switches in the interventional arm in which quantitative brain MRI played a role in the clinical decision-making process to switch DMT.

Time frame: baseline

Neurologist confidence in the clinical decision-making process (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)

Difference between control and interventional arm in the average confidence of the neurologist in the clinical decision-making process at baseline.

Time frame: baseline

Neurologist confidence in confirming the diagnosis of MS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)

Difference between control and interventional arm in the average confidence of the neurologist in confirming diagnosis of MS at baseline.

Time frame: baseline

Neurologist confidence in confirming the conversion to SPMS (Likert scale: 1 - not confident, 2 - slightly confident, 3 - somewhat confident, 4 - fairly confident, 5 - very confident)

Difference between control and interventional arm in the average confidence of the neurologist in confirming conversion to SPMS at baseline.

Time frame: baseline

Proportion of patients with detected smouldering or inflammatory disease components

The difference between control arm and interventional arm in the proportion of patients for whom smouldering or inflammatory disease components are reported by the neurologist at baseline.

Time frame: baseline

Reported MRI findings at baseline

Difference between control arm and interventional arm in the number of reported MRI findings at baseline, among: * new FLAIR lesions * enlarging FLAIR lesions * total FLAIR lesion volume * T1 hypointense lesions * T1 hyperintense lesions (if T1-post available) * whole brain volume loss * gray matter volume loss * central vein sign lesions (if SWI available) * paramagnetic rim lesions (if SWI available) * (cervical) spinal cord atrophy (if assessable)

Time frame: baseline

Proportion of patients with relapse associated worsening (RAW)

The difference between control arm and interventional arm in the proportion of patients for whom RAW disease activity or progression is reported by the neurologist at month 12 to month 24.