INFLANET - A French Network for PET imaging of neuroinflammation in MS

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients, Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

16 Dec 2025 → ongoing

Decision date (initial)

2024-05-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-510304-53-00

ClinicalTrials.gov

NCT06280742

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To quantify, in a multicentre trial applying [18F]-DPA-714 PET, the smoldering component of white matter lesions in people with multiple sclerosis (PwMS), as compared with [18F]-DPA-714 binding in the white matter of healthy controls who underwent a PET acquisition with the same camera than patients in each center.

Secondary objectives 1

1. 1) 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. 2) To assess the clinical relevance of inflammatory profiles derived from PET MR acquisitions with all the clinical and neuropsychological scores collected at baseline. 3) To improve the methodological workup for the quantification of multicenter PET data 4) To explore and assess the MRI signatures of each lesional subtypes, and the correlation between MRI metrics (T1, T2, FLAIR, SWI, QSM, MTR, ihMT, diffusion) and [18F]-DPA-714 DVR in each region of interest. This will include the assessment of novel algorithms that have been generated through deep learning and attempt to reproduce PET using multimodal MRI datasets.

Conditions and MedDRA coding

Multiple sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. RRMS patients: - Age between 18 and 55 years old - RRMS according to the 2017 Mc Donald criteria - Last treatment with methylprednisolone should have been performed at least 1 month before PET examinations - No current disease modifying therapy or under platform therapy (dimethyl fumarate, teriflunomide, beta-interferons, glatiramer acetate)- 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 1

1. 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) - PET for clinical research already done 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 1

1. - 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. - Clinical and neuropsychological scores collected at baseline - An accessible pipeline for the processing of DPA-714 data - MRI data

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Bruno Stankoff

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Bruno Stankoff

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications