Clinical trial NCT02858167: Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations
Official title: Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations: Study of Principal Inter-individual Variation Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Absence of neurological impairment detected during standard neurological examination
timeFrame: Day 0
measure: Mini-mental state score
timeFrame: Day 0
measure: Frontal Assessment Battery score
timeFrame: Day 0
measure: Mini International Neuropsychiatric Interview (DSM-IV) score
timeFrame: Day 0
measure: Montgomery-Åsberg depression rating scale
timeFrame: Day 0
measure: Absence of cerebral abnormalities detected with PET
timeFrame: Day 0
measure: Absence of cerebral abnormalities detected with X ray spiral CT
timeFrame: Day 0
Secondary outcomes:
measure: Instrumental Activities of Daily Living evaluation
timeFrame: Day 0
measure: Cerebral FDG distribution
timeFrame: Day 0
measure: FDG mean activity in cerebral sections
timeFrame: Day 0
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service de Médecine Nucléaire, Hôpital Central
Study officials:
affiliation: Service de Médecine Nucléaire, Hôpital Central, Nancy, France
name: Marie-Hélène Laurens
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Médecine Nucléaire, Hôpital Central, Nancy, France
name: Pierre-Yves MARIE
role: PRINCIPAL_INVESTIGATOR
References: