N,N-DIETHYL-2-(2-(4-(2[(18)F]-FLUOROETHOXY)PHENYL)5,7DIMETHYLPYRAZOLO[1,5A]PYRIMIDIN-3-YL)ACETAMIDE for Multiple sclerosis

Inclusion criteria

• {"criterion_text":"- RRMS patients: - Age between 18 and 55 years old"}
• {"criterion_text":"- RRMS according to the 2017 Mc Donald criteria"}
• {"criterion_text":"- Last treatment with methylprednisolone should have been performed at least 1 month before PET examinations"}
• {"criterion_text":"- No current disease modifying therapy or under platform therapy (dimethyl fumarate, teriflunomide, beta-interferons, glatiramer acetate)"}
• {"criterion_text":"- Indication for a highly active disease modifying treatment: Natalizumab, anti CD20 antibody, Alemtuzumab, sphingosine-1 phosphate modulator, or cladribine. This will consist either as patients with an active form of relapsing MS or patients who have experienced two relapses during the previous year"}
• {"criterion_text":"- Affiliation to a social security scheme or beneficiary of such a scheme (except “Aide Médicale d’Etat”)"}
• {"criterion_text":"- Healthy Volunteers: - Age between 18 and 55 years old"}
• {"criterion_text":"- Without any evolutive pathology"}
• {"criterion_text":"- Able to understand the study objectives and procedures"}
• {"criterion_text":"- Affiliation to a social security scheme or beneficiary of such a scheme (except “Aide Médicale d’Etat”)"}

Exclusion criteria

• {"criterion_text":"- all participants: - Any reasons, which does not allow to perform MRI, including claustrophobia, the implant of a pace-maker or the presence of an intra-ocular foreign body, (a contra-indication questionnaire will be filled in beforehand)"}
• {"criterion_text":"- PET for clinical research already done within the last 12 months"}
• {"criterion_text":"- Low Affinity Binding profile (analyse of TSPO polymorphism done at screening visit)"}
• {"criterion_text":"- Pregnancy, breast-feeding, lack of efficient contraception for women of childbearing potential"}
• {"criterion_text":"- Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary or cardiac disease, or any other chronic neurological diseases"}
• {"criterion_text":"- Unwillingness to be informed in case of unexpected MRI abnormality (with a significant medical anomaly)"}
• {"criterion_text":"- Patient under legal protection"}
• {"criterion_text":"- Participation in another interventional study or being in the exclusion period at the end of a previous study"}
• {"criterion_text":"- RRMS patients: - hypersensitivity to gadoteric acid - meglumine or any drug containing gadolinium"}
• {"criterion_text":"- Severe renal insufficiency (creatinine clearance < 60mL/min and GFR <30ml / min / 1.73m2)."}

Primary endpoints

• {"endpoint_text":"- The respective proportion of lesions classified as homogeneously active, rim active and inactive for every single patient with MS. Classification of lesions will be based on predefined data-driven threshold of activity in lesions subareas (Hamzaoui et al, 2023).","definition_or_measurement_approach":"Classification of lesions based on predefined data-driven threshold of activity in lesion subareas (Hamzaoui et al, 2023), measured using [18F]-DPA-714 PET (DVR/binding) comparisons between patients and healthy controls."}

Secondary endpoints

• {"endpoint_text":"- Regional mean and voxel wise individual maps of innate immune cells activation derived from baseline [18F]-DPA-714 PET : they will be expressed as mean DVR values and as percentage of voxel classified as “DPA+”, for each region of interest: whole brain, NAWM, grey matter, cortex, thalami, deep grey matter, white matter T2 lesions, white matter T1 lesions.","definition_or_measurement_approach":"Measured from baseline [18F]-DPA-714 PET: expressed as mean DVR values and percentage of voxels classified as “DPA+” for predefined regions of interest."}
• {"endpoint_text":"- Clinical and neuropsychological scores collected at baseline","definition_or_measurement_approach":"Baseline clinical and neuropsychological assessments collected per protocol (specific scales not detailed in provided JSON)."}
• {"endpoint_text":"- An accessible pipeline for the processing of DPA-714 data","definition_or_measurement_approach":"Development/availability of a processing pipeline for DPA-714 PET data (methodological deliverable)."}
• {"endpoint_text":"- MRI data","definition_or_measurement_approach":"MRI acquisitions (T1, T2, FLAIR, SWI, QSM, MTR, ihMT, diffusion) collected to explore correlations with PET metrics."}

France

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

559

Number Of Sites

8

Number Of Participants

50

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France