Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations
BDD TEP FDG
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lymphoma
Started Feb 2009
Typical duration for not_applicable lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedSeptember 15, 2016
September 1, 2016
4 years
July 29, 2016
September 13, 2016
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (3)
Instrumental Activities of Daily Living evaluation
Day 0
Cerebral FDG distribution
Day 0
FDG mean activity in cerebral sections
Day 0
Study Arms (1)
FDG-PET
EXPERIMENTALInterventions
FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Médecine Nucléaire, Hôpital Central
Nancy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Hélène Laurens
Service de Médecine Nucléaire, Hôpital Central, Nancy, France
- PRINCIPAL INVESTIGATOR
Pierre-Yves MARIE
Service de Médecine Nucléaire, Hôpital Central, Nancy, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 8, 2016
Study Start
February 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share