Multiple SclerosisINFLANETNCT06280742
Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET)
A study testing PET-MRI with [18F]-DPA-714 in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PET-MRI with [18F]-DPA-714
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesFrance
- Study dates
- 16 Dec 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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")
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Département de Neurologie,Pierre Wertheimer Neurological Hospital
Lyon, 69500
Françoise DURAND-DUBIEF, MD, 04 72 35 75 22 ext. +33, francoise.durand-dubief@chu-lyon.fr
- Recruiting
CERMEP
Lyon, 69677
Françoise DURAND-DUBIEF, MD, 04 72 35 75 22 ext. +33, francoise.durand-dubief@chu-lyon.fr
- Recruiting
CIC Neurosciences, GH Pitié-Salpêtrière
Paris, 75013
Bruno Stankoff, MD, 0171970659 ext. +33, bruno.stankoff@aphp.fr
- Not yet recruiting
Centre Eugène Marquis
Rennes, 35000
Xavier Palard, MD, 02 99 25 30 83 ext. +33, x.palard@rennes.unicancer.fr
- Not yet recruiting
Service de Neurologie, CHU Pontchaillou
Rennes, 35000
Anne Kerbrat, MD, 02 99 28 42 94 ext. +33, anne.kerbrat@chu-rennes.fr
- Not yet recruiting
CHU Toulouse - Département de Neurologie
Toulouse, 31300
Jonathan Ciron, Dr, 05 61 77 91 06 ext. +33, ciron.j@chu-toulouse.fr
- Not yet recruiting
CHU Toulouse - Service de médecine nucléaire
Toulouse, 31300
Pierre Payoux, Dr, 06 80 14 42 25 ext. +33, Payoux.p@chu-toulouse.fr
About this study
Official title: Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- PET-MRI with [18F]-DPA-714
- Keywords
- Multiple Sclerosis, PET-MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRI with [18F]-DPA-714Radiation
PET-MRI with [18F]-DPA-714
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | MRI with added injection of gadolinium Receives: Radiation: PET-MRI with [18F]-DPA-714 |
| Healthy Volunteers | Active comparator | Not described Receives: Radiation: PET-MRI with [18F]-DPA-714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Regional mean and voxel wise individual maps of innate immune cells activation derived from baseline [18F]-DPA-714 PET : they will be expressed as mean DVR values and as percentage of voxel classified as "DPA+", for each region of interest: whole brain, NAWM, grey matter, cortex, thalami, deep grey matter, white matter T2 lesions, white matter T1 lesions.
Measured: 26 month
The MRI signatures of each lesional subtypes, and correlation between MRI metrics and [18F]-DPA-714 DVR in each region of interest.
MRI data: T1, T2, FLAIR, SWI, QSM, MTR, ihMT, diffusion collected at baseline. This will include the assessment of novel algorithms that have been generated through deep learning and attempt to reproduce PET using multimodal MRI datasets.
Measured: 26 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280742
- Sponsor's protocol ID
- APHP221366
- Acronym
- INFLANET
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT06280742
- Acronym / sponsor ID
- INFLANET / APHP221366
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, PET-MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Radiation: PET-MRI with [18F]-DPA-714MRI with added injection of gadolinium |
| Healthy Volunteers | Active comparator | Radiation: PET-MRI with [18F]-DPA-714 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRI with [18F]-DPA-714PET-MRI with [18F]-DPA-714 | Radiation | Healthy Volunteers, Patients |
Primary outcome
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.
Time frame: 26 month
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).
2 secondary outcomes
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.
Time frame: 26 month
The MRI signatures of each lesional subtypes, and correlation between MRI metrics and [18F]-DPA-714 DVR in each region of interest.
Time frame: 26 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI with [18F]-DPA-714 in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Stankoff, MD (0171970659 ext. +33, bruno.stankoff@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 26 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.