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

NCT06280742 | Recruiting

• 1 other identifier: APHP221366
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; PET-MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  26 month

Secondary Outcomes (2)

• 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

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

  26 month

Study Arms (2)

Patients

EXPERIMENTAL

MRI with added injection of gadolinium

Radiation: PET-MRI with [18F]-DPA-714

Healthy Volunteers

ACTIVE COMPARATOR

Radiation: PET-MRI with [18F]-DPA-714

Interventions

PET-MRI with [18F]-DPA-714 RADIATION

PET-MRI with \[18F\]-DPA-714

Healthy Volunteers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (7)

Département de Neurologie,Pierre Wertheimer Neurological Hospital

Lyon, 69500, France

RECRUITING

CERMEP

Lyon, 69677, France

RECRUITING

CIC Neurosciences, GH Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Centre Eugène Marquis

Rennes, 35000, France

NOT YET RECRUITING

Service de Neurologie, CHU Pontchaillou

Rennes, 35000, France

NOT YET RECRUITING

CHU Toulouse - Département de Neurologie

Toulouse, 31300, France

NOT YET RECRUITING

CHU Toulouse - Service de médecine nucléaire

Toulouse, 31300, France

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Bruno Stankoff, MD

CONTACT

0171970659; bruno.stankoff@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 28, 2024
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)