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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02858167
Acronym
BDD TEP FDG
Enrollment
100
Registered
2016-08-08
Start date
2009-02-28
Completion date
2013-02-28
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

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.

Interventions

DEVICEFDG-PET

FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Absence of cerebral abnormalities detected with X ray spiral CTDay 0
Mini International Neuropsychiatric Interview (DSM-IV) scoreDay 0
Montgomery-Åsberg depression rating scaleDay 0
Absence of cerebral abnormalities detected with PETDay 0
Absence of neurological impairment detected during standard neurological examinationDay 0
Mini-mental state scoreDay 0
Frontal Assessment Battery scoreDay 0

Secondary

MeasureTime frameDescription
Cerebral FDG distributionDay 0Voxel-based analysis with SPM software of PET data
FDG mean activity in cerebral sectionsDay 0Automatic measurement of FDG mean fixation in cerebral sections with NeurogamTM (Segami) software in PET data
Instrumental Activities of Daily Living evaluationDay 0Evaluation of the normality of cerebral function in study population

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026