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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06280742
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Additional Details

INFLANET is a multicentric, prospective, non-randomized, non-blinded, interventional study.The study will include a total of 41 participants, with 18 individuals diagnosed with multiple sclerosis (MS) distributed across three sites (6 patients per site: Paris, Lyon, Rennes). Additionally, there will be 23 healthy volunteers (HV), with 20 HV allocated to the Lyon and Rennes sites (10 HV per site) and 3 HV for the Paris site. The study involves several clinical visits, with two visits for patients (Screening V0 and Baseline V1), two visits for 20 healthy volunteers (Screening V0 and Baseline V1), and three visits for three healthy volunteers (Screening V0, Baseline V1

- Test, and V1' - Retest, in Paris site).

Various evaluations are integrated into the study, including neurological assessments at the screening visit, neuropsychological assessments at the baseline visit, 18F-DPA714 PET-MR or PET + MRI (n=1 for 20 HV and 18 subjetcs with MS; n=2 for 3 HV) at V1 and V1', and blood sampling at the screening visit to confirm TSPO eligibility. The PET-MR procedure involves TSPO PET using [18F]-DPA-714 in conjunction with 3T MRI for both MS patients and healthy volunteers. Gadoteric acid is administered for MS patients only as part of the imaging.

Arms & Interventions

Arms

Experimental: Patients

MRI with added injection of gadolinium

Active Comparator: Healthy Volunteers

Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.