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New treatment option for Multiple Sclerosis
Official title Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET)
ClinicalTrials.gov ID: NCT06280742
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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...
- 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...
See the full eligibility 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...
- 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")
- 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 treatment 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).
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Paris, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Paris, France; Rennes, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.