An interventional study of 18F-DPA-714 and 18F-FDG in Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive and Multiple Sclerosis, Primary Progressive, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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.
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:
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
This study will be performed by complementary teams already collaborating on molecular imaging trials in MS (which assess neuronal loss or demyelination/remyelination): i) the "Centre d'Investigation Clinique" (Salpetriere hospital, Paris), which is strongly experienced in the coordination of clinical and translational research on MS; ii) the CENIR (centre for neuroimaging research, Salpetriere hospital, Paris) a specialized MRI centre for research on neurological diseases; iii) the SHFJ (DSV, CEA, ORSAY) which is a world class molecular imaging centre;
Study duration Per patient the study will last two years Per control the study will last up to 8 weeks
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 61 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers (group I, n=20)
Patients with relapsing-remitting MS (group II, n=15)
Patients with progressive MS (group III and IV, n=15 per group)
Exclusion criteria
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.
Drug: 18F-DPA-714 and 18F-FDG
Positron emission tomography (PET) imaging following the injection of 2 radiotracers (here considered as the drugs): 1) 18F-DPA-714 ii) 18F-FDG. PET -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.
Whole brain Binding Potential (BP) of 18F-DPA-714
Quantification of microglial compartmentalized inflammation within the brain by PET with 18F-DPA-714 in MS patients and healthy controls
Time frame: D0
Binding potential of 18F-DPA-714 in segmented brain regions
To compare binding potential of 18F-DPA-714 in segmented brain regions: white matter, gray matter, white matter lesions
Time frame: D0
Binding potential of 18F-DPA-714 in subgroups of MS patients
To compare binding potential of 18F-DPA-714 in subgroups of MS patients (secondary progressive, primary progressive, relapsing remitting)
Time frame: D0
Predictive value of PET 18F-DPA-714 BP on neurological clinical metrics
To determine the predictive value of brain microglial inflammation on subsequent neurological impairment progression after a follow up period of two years.
Time frame: 2 years
Predictive value of PET 18F-DPA-714 BP on MRI metrics
To determine the predictive value of brain microglial inflammation on subsequent brain atrophy progression after a follow up period of two years.
Time frame: 2 years
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris