RecruitingNot a drug-phase studyRelapsing MSNCT062807422023-510304-53-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • PET-MRI with [18F]-DPA-714
  • N,N-DIETHYL-2-(2-(4-(2[(18)F]-FLUOROETHOXY)PHENYL)5,7DIMETHYLPYRAZOLO[1,5A]PYRIMIDIN-3-YL)ACETAMIDE

What it measured

Main measures

  • To quantify the smoldering component of white matter lesions in people with MS, as compared with [18F]-DPA-714 binding in the white matter of HC who underwent a PET a acquisition with the same camera camera than patients in each center.

    26 month

    MRI lesions
  • 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).

    MRI lesions

Other measures (3)

  • To quantify for each patient the regional neuroinflammatory load, measured as [18F]-DPA-714 DVR, in specific regions of interest: total brain, normal appearing white matter, cortex, thalami, deep grey matter.

    26 month

    MRI lesionsBrain volume lossImmune response
  • The MRI signatures of each lesional subtypes, and correlation between MRI metrics and [18F]-DPA-714 DVR in each region of interest.

    26 month

    MRI lesionsMyelin repair
  • - 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

    MRI lesionsBrain volume lossImmune response

Who could take part

Relapsing MS · 18 to 64

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).

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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]-DPA-714 PET imaging in MS, so far limited to monocentric studies. The objectives of the INFLANET project are (1) to conduct the first multicenter study assessing neuroinflammation in patients with active MS using [18F]DPA-714 PET tracer, and (2) to establish a methodology suitable for the quantification of multicenter PET data obtained with [18F]DPA-714. The INFLANET initiative aims to disseminate TSPO PET within the French MS research community, thereby opening the unique perspective of future large-scale, multicenter studies. These endeavors are expected to enhance our capacity to predict diseases, stratify patients, and assess new therapeutic interventions.

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History

    1. Started

      Dec 2025

    2. Main results due

      Dec 2028

    3. Finished

      Dec 2028

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