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Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET)

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

The Service Hospitalier Frédéric-Joliot (SHFJ) and Paris Brain Institute (ICM) groups have identified \[18F\]-DPA-714 as a promising second-generation TSPO tracer, a macromolecule overexpressed in neuroinflammatory conditions, for PET imaging. They have also developed a non-invasive quantification methodology, enabling the generation of individual neuroinflammation maps in MS patients. Recent findings from \[18F\]-DPA-714 PET imaging in MS patients revealed that most of the white matter lesions contained a smoldering component, even when considered inactive on MRI, and that their neuroinflammatory profiles were associated with longitudinal disability worsening. The Inflanet project aims to leverage a unique consortium comprising French radiochemists, radiopharmacists, nuclear medicine/neuroimaging experts, and MS neurologists to establish the first national network dedicated to \[18F\]-D

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: RRMS patients: * Age between 18 and 55 years old * RRMS according to the 2017 Mc Donald criteria * At least 9 supra-tentorial white matter lesions on T2/FLAIR MRI * Last treatment with methylprednisolone should have been performed at least 1 month before PET examinations * No current disease modifying therapy * 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") Exclusion Criteria: For 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) * Realization of any test using radioactivity 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).
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What it tests

  • PET-MRI with [18F]-DPA-714
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Where

7 sites
Département de Neurologie,Pierre Wertheimer Neurological Hospital
Lyon, France
CERMEP
Lyon, France
CIC Neurosciences, GH Pitié-Salpêtrière
Paris, France
Centre Eugène Marquis
Rennes, France
Service de Neurologie, CHU Pontchaillou
Rennes, France
CHU Toulouse - Département de Neurologie
Toulouse, France
CHU Toulouse - Service de médecine nucléaire
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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