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Imaging of Intracerebral Inflammation in MS

NCT02305264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-09-16

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Secondary Progressive
  • Multiple Sclerosis, Primary Progressive

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bruno Stankoff · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-19
Primary Completion
2018-09-10
Completion
2018-09-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305264 on ClinicalTrials.gov