Imaging of Intracerebral Inflammation in the Progressive Phase of Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Whole brain Binding Potential (BP) of 18F-DPA-714
Study Overview
Brief 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.
Detailed Description
Study design This study is a prospective cross-sectional controlled multicentric clinical study in 45 MS patients and 20 controls.
Four groups of person will be included and compared:
- Group I: 20 healthy volunteers aging from 18 to 65 years. These healthy volunteers will be matched for age and sex with patients (1/2).
- Group II: 15 patients aging from 18 to 65 years with relapsing-remitting (RRMS), with less than 10 years of evolution since the first manifestation and no recent relapse.
- Group III: 15 patients aging from 18 to 65 years with secondary progressive MS (SPMS), with less than 10 years of evolution since the occurrence of the secondary progressive phase.
- Group III: 15 patients aging from 18 to 65 years with primary progressive MS (PPMS) diagnosed since less than 10 years.
Study centres MS patients and the 20 healthy volunteers will be recruited in the Hospital Pitie-Salpetriere
MS patients will be recruited in the Hospital Tenon
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PET -18F-DPA-714 and 18F-FDG
18F-DPA-714, dose 5mCi (185MBq), will be injected via an arm intravenous catheter.
18F-FDG , dose 5mCi(185MBq), will be injected via an arm intravenous catheter.
Intervention: 18F-DPA-714 and 18F-FDG (Drug)
Outcomes
Primary Outcomes
Whole brain Binding Potential (BP) of 18F-DPA-714
Time Frame: D0
Quantification of microglial compartmentalized inflammation within the brain by PET with 18F-DPA-714 in MS patients and healthy controls
Secondary Outcomes
- Binding potential of 18F-DPA-714 in subgroups of MS patients(D0)
- Predictive value of PET 18F-DPA-714 BP on MRI metrics(2 years)
- Binding potential of 18F-DPA-714 in segmented brain regions(D0)
- Predictive value of PET 18F-DPA-714 BP on neurological clinical metrics(2 years)