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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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)

Locations
Other Locations
France
CERMEP
RECRUITING
Lyon
Département de Neurologie,Pierre Wertheimer Neurological Hospital
RECRUITING
Lyon
CIC Neurosciences, GH Pitié-Salpêtrière
RECRUITING
Paris
Centre Eugène Marquis
NOT_YET_RECRUITING
Rennes
Service de Neurologie, CHU Pontchaillou
NOT_YET_RECRUITING
Rennes
CHU Toulouse - Département de Neurologie
NOT_YET_RECRUITING
Toulouse
CHU Toulouse - Service de médecine nucléaire
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Bruno Stankoff, MD
bruno.stankoff@aphp.fr
0171970659
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2028-12
Participants
Target number of participants: 41
Treatments
Experimental: Patients
MRI with added injection of gadolinium
Active_comparator: Healthy Volunteers
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov