Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations

Study Overview
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Brief Summary
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The purpose of this study is to define a reference population for FDG-PET neurological examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma (tumor in remission, low disabling chronic tumor).

Detailed Description
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This study will also check normality of cerebral functions in this population and analyse the influence of various variation factors, such as age, sex ratio, education level, professional activity and neuropsychological test results on normal data. This database could be later used as comparison to patient images defining the gravity and localization of their cerebral functional disorders.

Official Title
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Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations: Study of Principal Inter-individual Variation Factors

Conditions
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Lymphoma

Intervention / Treatment
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* Device: FDG-PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with tumor in remission or low disabling chronic tumor No parenteral chemotherapy for at least 1 month No glucocorticoid treatment No general health modification (asthenia, anorexia, weight reduction) Exclusion Criteria: Patient having a known neurodegenerative disorder, a general disease or physical problems that can interfere with cognitive function Patient with cerebral pathology history (epilepsy, vascular event, cerebral vascular malformation, tumor, severe cranial trauma, meningitis or infectious or inflammatory encephalitis, hydrocephalus, mental retardation…) Patient not having at least 4 years of education Patient having an anxiolytic or anti-depressive treatment Patient refusing to participate to the study Patient incapable to give informed consent (guardianship)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDG-PET<br> | Device: FDG-PET<br>* FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of neurological impairment detected during standard neurological examination |  | Day 0 | 
| Mini-mental state score |  | Day 0 | 
| Frontal Assessment Battery score |  | Day 0 | 
| Mini International Neuropsychiatric Interview (DSM-IV) score |  | Day 0 | 
| Montgomery-Åsberg depression rating scale |  | Day 0 | 
| Absence of cerebral abnormalities detected with PET |  | Day 0 | 
| Absence of cerebral abnormalities detected with X ray spiral CT |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental Activities of Daily Living evaluation | Evaluation of the normality of cerebral function in study population | Day 0 | 
| Cerebral FDG distribution | Voxel-based analysis with SPM software of PET data | Day 0 | 
| FDG mean activity in cerebral sections | Automatic measurement of FDG mean fixation in cerebral sections with NeurogamTM (Segami) software in PET data | Day 0 |