NCT03825601Completed
PET with [18F]Flumazenil As an Index of Neurodegeneration in MS
PET with [18F]Flumazenil As an Index of Neurodegeneration in MS: Sensitivity At an Early Disease Stage and Pathophysiological Meaning
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
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 complex and pluriform, ranging from cortical demyelinating lesions, synapse and dendrite disappearance to neuronal cell death. Current Magnetic Resonance Imaging MRI techniques fail to fully assess and quantify grey matter pathology in this disease. The development of a quantitative marker of neurodegeneration for MS patients would allow: (i) to better understand the pathophysiological mechanisms underlying the distinct forms of MS; (ii) to stratify patients according to their prognosis; and (iii) to evaluate new therapies aimed at promoting neuroprotection. would allow to better understand the mechanisms underlying the distinct forms of MS, to stratify patients according to their prognosis, and to evaluate new therapies aimed at promoting neuroprotection.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 21 Jan 2019
- Start date
- 2 May 2019
- Primary completion date
- 26 Aug 2024
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Multiple sclerosis
- NCT number
- NCT03825601
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 2 May 2019 to the primary completion date, 26 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Radiation exposure during the last year before inclusion due to prior participations to other research protocols
Other illness
- Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal pulmonary or cardiac disease.
- Other chronic neurological diseases.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre d'Investigation Clinique de Neuroscience, Groupe Hospitalier Pitié Salpêtrière, ICM, Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.