Status:
COMPLETED
PET with [18F]Flumazenil As an Index of Neurodegeneration in MS
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Beyond white matter pathology, grey matter damage is considered as a key player in disability onset and progression in Multiple Sclerosis (MS). The underlying substratum of grey matter damage is compl...
Detailed Description
The investigators have recently shown that PET (Tomographie par Émission de Positrons) with \[11C\]Flumazenil (\[11C\]FMZ), that binds to the benzodiazepine site of GABA-A receptors, allowed to quanti...
Eligibility Criteria
Inclusion
- Patient group:
- Aged 18-55 years old
- Diagnosis of RRMS or PPMS according to the 2010 Mc Donald criteria
- Disease duration \< 10 years
- Able to understand the study objective and procedure
- Efficient contraception for women of potential child-bearing
- Inscription to the national health care system
- Having signed the written consent form
- No current benzodiazepine or other GABAA-interacting drug (that have to be stopped 15 days before inclusion)
- Accept to be informed of any incidental finding on imaging acquisitions
- Healthy subjects
- Aged 18-55 years old
- No evolutive pathology
- Able to understand the study objective and procedure
- Efficient contraception for women of potential child-bearing
- Inscription to the national health care system
- Having signed the written consent form
- No concurrent benzodiazepine or other GABAA-interacting drug treatment (that have to be stopped 15 days before inclusion)
- Accept to be informed of any incidental finding on imaging acquisitions
Exclusion
- Any reason, which does not allow to perform MRI, including claustrophobia, the implant of a pace-maker or the presence of an intra-ocular foreign body.
- For women: pregnancy, lactation, lack of efficient contraception. A positive pregnancy test conducted at visit 2 will lead to the immediate exclusion of the subject.
- Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal pulmonary or cardiac disease.
- Radiation exposure during the last year before inclusion due to prior participations to other research protocols
- Other chronic neurological diseases.
Key Trial Info
Start Date :
May 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03825601
Start Date
May 2 2019
End Date
August 26 2024
Last Update
March 5 2025
Active Locations (1)
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1
Centre d'Investigation Clinique de Neuroscience, Groupe Hospitalier Pitié Salpêtrière, ICM, Pitié Salpêtrière
Paris, France, 75651