Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06280742

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-06

41

Participants Needed

7

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 55 years old for RRMS patients and healthy volunteers
  • Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to 2017 McDonald criteria (for RRMS patients)
  • At least 9 supratentorial white matter lesions on T2/FLAIR MRI (for RRMS patients)
  • Last methylprednisolone treatment at least 1 month before PET scans (for RRMS patients)
  • No current disease-modifying therapy (for RRMS patients)
  • Indication for highly active disease-modifying treatment due to active relapsing MS or two relapses in previous year (for RRMS patients)
  • Affiliation to a social security scheme or beneficiary (except Aide Médicale d'Etat)
Not Eligible

You will not qualify if you...

  • Any condition preventing MRI, including claustrophobia, pacemaker, or intra-ocular foreign body
  • Any radioactive test performed within last 12 months
  • Low Affinity Binding profile based on TSPO polymorphism analysis
  • Pregnancy, breastfeeding, or lack of effective contraception in women of childbearing potential
  • Severe or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac disease, or other chronic neurological diseases
  • Unwillingness to be informed of unexpected significant MRI abnormalities
  • Under legal protection
  • Participation in another interventional study or within exclusion period of previous study
  • Hypersensitivity to gadoteric acid, meglumine, or gadolinium-containing drugs (for RRMS patients)
  • Severe renal insufficiency with creatinine clearance < 60 mL/min or GFR < 30 mL/min/1.73 m2 (for RRMS patients)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Département de Neurologie,Pierre Wertheimer Neurological Hospital

Lyon, France, 69500

Actively Recruiting

2

CERMEP

Lyon, France, 69677

Actively Recruiting

3

CIC Neurosciences, GH Pitié-Salpêtrière

Paris, France, 75013

Actively Recruiting

4

Centre Eugène Marquis

Rennes, France, 35000

Not Yet Recruiting

5

Service de Neurologie, CHU Pontchaillou

Rennes, France, 35000

Not Yet Recruiting

6

CHU Toulouse - Département de Neurologie

Toulouse, France, 31300

Not Yet Recruiting

7

CHU Toulouse - Service de médecine nucléaire

Toulouse, France, 31300

Not Yet Recruiting

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Research Team

B

Bruno Stankoff, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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