CompletedNot Applicable

Imaging of Intracerebral Inflammation in MS

France61 participantsStarted 2012-03-19

Plain-language summary

In this study we plan to image the compartmentalized inflammation in MS using molecular imaging by positron emission tomography (PET) with a very highly resolutive camera. Two tracers will be studied and compared: i) \[18F\]DPA-714, which bind to the peripheral benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This new ligand for PBR displays several advantages compared to the existing reference compound PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility with \[18F\] ii) \[18F\]-fluoro-desoxy-glucose (\[18F\]FDG), which should reflect glucose metabolism in activated immune cells in the white matter. Progressive MS patients (secondary progressive and primary progressive) will be compared to relapsing-remitting patients and to healthy volunteers. All subjects will pass a complete neurological evaluation and a multimodal MRI to document clinical disability and tissue injury. A clinical and radiological follow up will then be performed for a 2-year period. This study should help to understand the contribution of the intracerebral inflammation on the progression of disability and could provide a surrogate marker for further therapeutic trials in chronic progressive MS.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria Healthy volunteers (group I, n=20) * Aged 18-65 years; * Able to understand the objectives and procedures of the study, and who give inform consent. Patients with relapsing-remitting MS (group II, n=15) * Aged 18-65 years * Clinically definite MS according to McDonald revised criteria * Less than 10 year of evolution * No clinical relapse during the past 3 months * Able to understand the objectives and procedures of the study, and who give inform consent Patients with progressive MS (group III and IV, n=15 per group) * Aged 18-65 years * Clinically definite MS according to McDonald revised criteria * SPMS evolving since more than 10 years for group III (n = 15). * PPMS evolving since less than 10 years for group IV (n=15). * Each progressive patient should have experienced a significant progression during the 2 years preceding the inclusion (with an estimated progression of the EDSS score of at least 0.5 point). * No clinical relapse during the past 3 months * Able to understand the objectives and procedures of the study, and who give inform consent. Exclusion criteria * Any reason, which does not allow performing MRI: claustrophobia, pace-maker or intra-ocular foreign body for example. * For women: pregnancy, lactation, lack of efficient contraception. At visit 2, a positive pregnancy test will lead to exclude the patient. * Uncontrolled diabetes * Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal pulmonary …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Whole brain Binding Potential (BP) of 18F-DPA-714

Timeframe: D0

Trial details

NCT IDNCT02305264

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-10

View on ClinicalTrials.gov More Multiple Sclerosis, Relapsing-Remitting trials