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

Not Applicable

Completed

• Conditions: Lymphoma
• Interventions: Device: FDG-PET

• Registration Number: NCT02858167
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG-PET	FDG-PET	-

Primary Outcome Measures

Name	Time	Method
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
Absence of cerebral abnormalities detected with PET	Day 0
Absence of cerebral abnormalities detected with X ray spiral CT	Day 0
Montgomery-Åsberg depression rating scale	Day 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de Médecine Nucléaire, Hôpital Central; 🇫🇷 Nancy, France