Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis

Study Overview
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Brief Summary
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PET imaging of activated microglia offers a tool of investigation of a range of brain diseases where neuroinflammation is a component. Amyotrophic lateral sclerosis is the most frequent motoneuronal disease in adult. This study was designed to explore the feasibility of molecular imaging modality by Positron Emission Tomography using 18F-X as an in vivo marker of activated microglia for the assessment of neuroinflammation in amyotrophic lateral sclerosis. PET may help in the diagnosis of the disease and, further, may allow assessment of the efficacy of antiinflammatory treatment.

Detailed Description
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18F-X PET will be carried out requiring arterial sampling in 2 patients suffering from ALS and 2 normal subjects in order to evaluate the 18F-X quantification. Then simplified PET using 18F-X will be carried out in 13 patients and 13 normal subjects. Binding potential maps showing specific binding of 18f-X will be generated for each subject. Regional binding potential values will be calculated for anatomically defined regions of interest after coregistration to and special transformation into the subject's own MRI.

Official Title
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Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis, Bulbar Disease, Spinal Disease

Intervention / Treatment
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* Radiation: 18F-X PET SCAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suffering from probable or definite form of amyotrophic lateral sclerosis according to El Escorial criteria. Spinal or bulbar site of the disease. Information and signature of the written consent form French Social Security registration Exclusion Criteria: family history of ALS Riluzole treatment before the first PETscan. Psychiatric disorders Evolution of the disease older than 18 months Antiinflammatory or antibiotic treatment in the last month

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>18F-X PET Scan imaging | Radiation: 18F-X PET SCAN<br>* 18F-X PET Scan : Injection of 7.8 mSv for 370 MBq of dose (0.021 mSv / MBq)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative in vivo-imaging of 18F-X microglial binding site as a mesure of disease activity followed up by non invasive quantification of patients using imaging modality. |  | Inclusion period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of the localisation of benzodiazepine binding site related to microglial activation in ALS |  | inclusion period | 
| Evidence of the difference of microglial localisation and activation between bulbar and spinal form of amyotrophic lateral sclerosis |  | inclusion period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurology, sclerosis, imaging, tomography