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Completed

NCT Number: NCT02858167

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

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).

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Nucléaire, Hôpital Central

Nancy, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FDG-PET

Device

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

Primary outcomes

  1. Absence of neurological impairment detected during standard neurological examination

    Time frame: Day 0

  2. Mini-mental state score

    Time frame: Day 0

  3. Frontal Assessment Battery score

    Time frame: Day 0

  4. Mini International Neuropsychiatric Interview (DSM-IV) score

    Time frame: Day 0

  5. Montgomery-Åsberg depression rating scale

    Time frame: Day 0

  6. Absence of cerebral abnormalities detected with PET

    Time frame: Day 0

  7. Absence of cerebral abnormalities detected with X ray spiral CT

    Time frame: Day 0

Secondary outcomes

  1. Instrumental Activities of Daily Living evaluation

    Time frame: Day 0

    Evaluation of the normality of cerebral function in study population

  2. Cerebral FDG distribution

    Time frame: Day 0

    Voxel-based analysis with SPM software of PET data

  3. FDG mean activity in cerebral sections

    Time frame: Day 0

    Automatic measurement of FDG mean fixation in cerebral sections with NeurogamTM (Segami) software in PET data

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: BDD TEP FDG

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2016
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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