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This will include the assessment of novel algorithms that have been generated through deep learning and attempt to reproduce PET using multimodal MRI datasets.","secondaryObjectiveTranslations":[{"id":11586065,"uuid":"2bc129c1-2b8e-4cb5-a803-64c97faf8bd6","attributeTranslation":"1) Quantifier pour chaque patient la charge neuroinflammatoire locale, mesurée par le [18F]-DPA-714 DVR, dans des régions d'intérêt spécifiques : cerveau total, substance blanche d'apparence normale, cortex, thalami, substance grise profonde.\n2) Évaluer la pertinence clinique des profils inflammatoires acquis en TEP-IRM avec tous les scores cliniques et neuropsychologiques recueillis à la baseline.\n3) Améliorer l'élaboration méthodologique pour la quantification des données TEP multicentriques.\n4) Explorer et évaluer les signatures IRM de chaque sous-type de lésion et la corrélation entre les paramètres IRM (T1, T2, FLAIR, SWI, QSM, MTR, ihMT, diffusion) et le [18F]-DPA-714 DVR dans chaque région d'intérêt. Cela comprendra l'évaluation de nouveaux algorithmes qui ont été générés par deap learning et qui tentent de reproduire la TEP en utilisant des ensembles de données d'IRM multimodales.","language":10,"languageDescription":"French"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":936104,"number":1,"principalInclusionCriteria":"RRMS patients: - Age between 18 and 55 years old - RRMS according to the 2017 Mc Donald criteria - Last treatment with methylprednisolone should have been performed at least 1 month before PET examinations - No current disease modifying therapy or under platform therapy (dimethyl fumarate, teriflunomide, beta-interferons, glatiramer acetate)- 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 - Affiliation to a social security scheme or beneficiary of such a scheme (except “Aide Médicale d’Etat”) Healthy Volunteers: - Age between 18 and 55 years old - Without any evolutive pathology - Able to understand the study objectives and procedures - Affiliation to a social security scheme or beneficiary of such a scheme (except “Aide Médicale d’Etat”)","principalInclusionCriteriaTranslations":[{"id":11586062,"uuid":"16dbb699-960b-44bd-8cee-c1ec598f06d2","attributeTranslation":"Patients SEP-RR: 1. Âge compris entre 18 et 55 ans 2. SEP-RR selon les critères 2017 de Mc Donald 3. Le dernier traitement à la méthylprednisolone doit avoir été effectué au moins 1 mois avant les examens TEP. 4. Pas de traitement modificateur de la maladie en cours ou sous traitement plateforme (dimethyl fumarate, teriflunomide, beta-interferons, acetate de glatiramère) 5. Indication d'un traitement modificateur de la maladie hautement actif : Natalizumab, anticorps anti-CD20, Alemtuzumab, modulateur du phosphate de sphingosine-1 ou cladribine. Il s'agira soit de patients présentant une forme active de SEP récurrente, soit de patients ayant subi deux rechutes au cours de l'année précédente. 6 Affiliation à un régime de sécurité sociale ou bénéficiaire d'un tel régime (à l'exception de l'aide médicale d'État).\nVolontaires sains : 1. Âge compris entre 18 et 55 ans 2. Sans pathologie évolutive 3. Capable de comprendre les objectifs et les procédures de l'étude 4. Affiliation à un régime de sécurité sociale ou bénéficiaire d'un tel régime (à l'exception de l'Aide Médicale d'Etat)","language":10,"languageDescription":"French"}]}],"principalExclusionCriteria":[{"id":1599581,"number":1,"principalExclusionCriteria":"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) - PET for clinical research already done within the last 12 months - Low Affinity Binding profile (analyse of TSPO polymorphism done at screening visit) - Pregnancy, breast-feeding, lack of efficient contraception for women of childbearing potential - Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary or cardiac disease, or any other chronic neurological diseases - Unwillingness to be informed in case of unexpected MRI abnormality (with a significant medical anomaly) - Patient under legal protection - Participation in another interventional study or being in the exclusion period at the end of a previous study RRMS patients: - hypersensitivity to gadoteric acid - meglumine or any drug containing gadolinium - Severe renal insufficiency (creatinine clearance < 60mL/min and GFR <30ml / min / 1.73m2).","principalExclusionCriteriaTranslations":[{"id":11586060,"uuid":"668e3e87-dff4-4e13-8c8d-7ae81b711e99","attributeTranslation":"Pour tous les participants :\n1. Toute raison ne permettant pas de réaliser une IRM, y compris la claustrophobie, l'implantation d'un stimulateur cardiaque ou la présence d'un corps étranger intra-oculaire (un questionnaire de contre-indication sera rempli au préalable).\n2. PET pour la recherche clinique déjà effectuée au cours des 12 derniers mois\n3. Profil de liaison à faible affinité (analyse du polymorphisme TSPO effectuée lors de la visite de sélection)\n4. Grossesse, allaitement, absence de contraception efficace chez les femmes en âge de procréer*.\n5. Symptômes actuels d'une maladie rénale, hépatique, hématologique, gastro-intestinale, pulmonaire ou cardiaque grave ou non contrôlée, ou de toute autre maladie neurologique chronique.\n6. Refus d'être informé en cas d'anomalie inattendue à l'IRM (avec une anomalie médicale significative)\n7. Participant sous protection juridique\n8. Participation à une autre étude interventionnelle ou présence dans la période d'exclusion à la suite d’une étude antérieure.\nPatients SEP-RR\n1. Hypersensibilité à l'acide gadotérique, la méglumine ou à tout autre médicament contenant du gadolinium\n2. Insuffisance rénale sévère (clairance de la créatinine < 60mL/min et DFG < 30ml / min / 1,73m2).","language":10,"languageDescription":"French"}]}]},"endPoint":{"primaryEndPoints":[{"id":1093869,"number":1,"endPoint":"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).","isPrimary":true,"endPointTranslations":[{"id":11586058,"uuid":"94806933-5527-44dd-818e-918c063064cd","attributeTranslation":"La proportion respective de lésions classées comme étant homogènement actives, rim actives et inactives sera déterminée pour chaque patient atteint de SEP. La classification des lésions reposera sur un seuil prédéfini d'activité au sein des sous-zones telle que défini dans les travaux de Hamzaoui et al., 2023.","language":10,"languageDescription":"French"}]}],"secondaryEndPoints":[{"id":1093870,"number":1,"endPoint":"- 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. - Clinical and neuropsychological scores collected at baseline - An accessible pipeline for the processing of DPA-714 data - MRI data","isPrimary":false,"endPointTranslations":[{"id":11586059,"uuid":"ec57eb1f-bab2-4882-93b1-744ede2b44e2","attributeTranslation":"o Cartes locales moyennes et individuelles par voxel de l'activation des cellules immunitaires innées dérivées du [18F]-DPA-714 PET de base \no Scores cliniques et neuropsychologiques recueillis à la baseline\no Un pipeline accessible pour le traitement des données DPA-714\no Données IRM","language":10,"languageDescription":"French"}]}]},"trialDuration":{"estimatedEndDate":"2027-11-01","estimatedRecruitmentStartDate":"2025-09-01"},"sourceOfMonetarySupport":[],"populationOfTrialSubjects":{"ageRanges":[{"id":378295,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"},{"code":"1","name":"Healthy volunteers"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{"planToShareIPD":"2"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-08-13","conclusionDate":"2026-08-13","therapeuticAreas":[{"code":"10","name":"Diseases [C] - Nervous System Diseases [C10]"}],"medicalConditions":[{"id":144068,"medicalCondition":"Multiple sclerosis","isConditionRareDisease":false}],"sponsors":[{"id":156676,"primary":true,"publicContacts":[{"id":462478,"type":"Public","functionalName":"Pr Bruno Stankoff","functionalEmailAddress":"bruno.stankoff@aphp.fr","telephone":"0171970659","organisation":{"id":290858,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Assistance Publique Hopitaux De Paris","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100004082","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":462479,"type":"Scientific","functionalName":"Pr Bruno Stankoff","functionalEmailAddress":"bruno.stankoff@aphp.fr","telephone":"0171970659","organisation":{"id":290858,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Assistance Publique Hopitaux De Paris","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100004082","organisationLocationStatus":"Active"}}],"thirdParties":[],"organisation":{"id":290858,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Assistance Publique Hopitaux De Paris","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100004082","organisationLocationStatus":"Active"},"addresses":[{"id":286846,"organisation":{"id":290858,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Assistance Publique Hopitaux De Paris","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100004082","organisationLocationStatus":"Active"},"address":{"addressId":305981,"oneLine":"Porte 23, 1 Avenue Claude Vellefaux","addressLine1":"Porte 23","addressLine2":"1 Avenue Claude Vellefaux","addressLine3":"","addressLine4":"","city":"Paris Cedex 10","postcode":"75475","country":2012,"countryName":"France"},"isBusinessKeyValidated":true,"businessKey":"ORG-100004082"}],"isCommercial":false,"commercial":"Non-Commercial"}],"trialCategoryCode":"3","trialCategoryJustificationComment":"Utilisation of the [18F]-DPA-714 for PET imaging, and developed a non-invasive quantification methodology to generate individual maps of neuroinflammation in patients with MS compared to healthy volunteers. 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