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

Lymphoma Clinical Trial

— BDD TEP FDG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858167
• Other study ID #: 2008-A00763-52
• Status: Completed
• Phase: N/A
• First received: July 29, 2016
• Last updated: September 13, 2016
• Start date: February 2009
• Est. completion date: February 2013

Study information

• Verified date: September 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	Service de Médecine Nucléaire, Hôpital Central	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of neurological impairment detected during standard neurological examination		Day 0	No
Primary	Mini-mental state score		Day 0	No
Primary	Frontal Assessment Battery score		Day 0	No
Primary	Mini International Neuropsychiatric Interview (DSM-IV) score		Day 0	No
Primary	Montgomery-Åsberg depression rating scale		Day 0	No
Primary	Absence of cerebral abnormalities detected with PET		Day 0	No
Primary	Absence of cerebral abnormalities detected with X ray spiral CT		Day 0	No
Secondary	Instrumental Activities of Daily Living evaluation	Evaluation of the normality of cerebral function in study population	Day 0	No
Secondary	Cerebral FDG distribution	Voxel-based analysis with SPM software of PET data	Day 0	No
Secondary	FDG mean activity in cerebral sections	Automatic measurement of FDG mean fixation in cerebral sections with NeurogamTM (Segami) software in PET data	Day 0	No