PET‑MRI with [18F]-DPA-714 to map neuroinflammation in multiple sclerosis

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

This study will test whether the PET‑MRI tracer [18F]-DPA-714 can map neuroinflammation in adults with relapsing‑remitting multiple sclerosis and in healthy volunteers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Drugs / interventions: Natalizumab, Alemtuzumab
• Locations: 7 sites (Lyon and 6 other locations)
• Trial ID: NCT06280742 on ClinicalTrials.gov

What this trial studies

INFLANET is a prospective, multicenter imaging study using the second‑generation TSPO tracer [18F]-DPA-714 combined with 3T MRI to create individual neuroinflammation maps. The project enrolls 18 people with relapsing‑remitting MS and 23 healthy volunteers across three French sites (Paris, Lyon, Rennes) and includes clinical and neuropsychological assessments, blood sampling for TSPO eligibility, and one or two PET‑MR sessions per participant. The protocol is non-randomized and non-blinded and applies a non‑invasive quantification method previously developed by the consortium. The aim is to standardize and validate PET‑MR imaging with [18F]-DPA-714 across centers to better characterize inflammatory activity in MS lesions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–55 with relapsing‑remitting MS, at least nine supratentorial white‑matter lesions on MRI, not currently on disease‑modifying therapy, and who are candidates for highly active treatments.

Not a fit: People without RRMS, those outside the 18–55 age range, patients currently on disease‑modifying therapies, or those with too few white‑matter lesions are unlikely to benefit from this imaging study.

Why it matters

Potential benefit: If successful, this could provide clinicians a clearer, non‑invasive way to detect active neuroinflammation and identify lesions more likely to drive future disability.

How similar studies have performed: Previous single‑center PET studies with [18F]-DPA-714 have shown smoldering inflammation in MS lesions and links to worsening disability, but multicenter validation is still limited.

Eligibility criteria

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).

Where this trial is running

Lyon and 6 other locations

• Département de Neurologie,Pierre Wertheimer Neurological Hospital — Lyon, France (RECRUITING)
• CERMEP — Lyon, France (RECRUITING)
• CIC Neurosciences, GH Pitié-Salpêtrière — Paris, France (RECRUITING)
• Centre Eugène Marquis — Rennes, France (NOT_YET_RECRUITING)
• Service de Neurologie, CHU Pontchaillou — Rennes, France (NOT_YET_RECRUITING)
• CHU Toulouse - Département de Neurologie — Toulouse, France (NOT_YET_RECRUITING)
• CHU Toulouse - Service de médecine nucléaire — Toulouse, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Bruno Stankoff, MD

Conditions: Multiple Sclerosis, PET-MRI