Database of Positon Emission Tomography (PET) Digital Brain Exams, in 50th Age of Patients

Neurodegenerative Diseases Clinical Trial

— BASITEP  

Official title:

Creation of a Database of PET Digital Brain Exams, Adapted to a Population Aged 50 Years and Over, to Help in the Interpretation of Fluoro Desoxy Glucose (FDG) Labelled With Fluor 18 (18F-FDG) PET/CT (Computer Tomography) Exam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163276
• Other study ID #: 2019PI238
• Status: Completed
• Start date: January 2, 2008
• Est. completion date: October 2020

Study information

• Verified date: November 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease.

Description:

The 18F-FDG cerebral PET can be performed for the detection of neurodegenerative diseases found hypometabolism in the areas concerned (Alzheimer's disease, fronto-temporal dementia, dementia Lewy body etc). The diagnosis is given by the clinician with a visual analysis of the data. Technical aids are now recommended (European recommendations) to complete the diagnosis with a quantitative analysis of different brain regions to a healthy brain base, to guide the diagnosis, in addition to visual analysis.

The emergence of a new technology has allowed the transition from analog PET / CT to digital PET / CT improving spatial resolution and image contrast. Unlike analog PET / CT that uses photomultipliers to detect light, digital PET / CT uses the digital photon counting technique to directly convert light into a digital signal and each crystal is connected to a single detector.

Different software, used in clinical routine, gives access to a quantified analysis of different areas of the brain. However, these programs have been made with healthy subjects of reduced strength (for example, the Neuro Q ® software database is based on 29 healthy patients), with no specific age and thanks to analog PET / CT ( old generation). There is therefore a low specificity in terms of detection of degenerative pathologies, this being explained by a decrease in cerebral metabolism with age 9, mainly at the level of the anterior areas 10 (frontal lobe, temporopolar areas, insular areas, cortex anterior cingulate).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2020
• Est. primary completion date: June 6, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having performed a 18F-FDG cerebral PET/CT exam as part of an Alzheimer's assessment at the Nuclear Medicine department of NANCY, sent by the Geriatric Department

• Patient who has received complete information on the organization of the research and who has not objected to the exploitation of this data

• Patient affiliated to a social security

Exclusion Criteria:

• patient who has received complete information on the organization of the research and who has objected to the exploitation of this data

• For patients with no abnormality in 18F-FDG PET, Mini Mental State Examination (MMSE) <25 or clinically diagnosed neurodegenerative pathology

• For patients with typical hypometabolism of 18F-FDG PET/CT, biology of cerebrospinal fluid not in favor of Alzheimer's disease

Related Conditions & MeSH terms

• Neurodegenerative Diseases

Intervention

Diagnostic Test:
• 18F FDG PET exam
All patients have received 18F-FDG PET/CT in nuclear medicine

Locations

Country	Name	City	State
France	University hospital of Nancy	Vandoeuvre-les-Nancy Cedex

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	GIE NANCYCLOTEP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	data base analysis	Comparison of Z-scores from PET/CT of the quantitative analysis of patients without abnormality of the brain metabolism and of typical Alzheimer patients (brain metabolism of the regions involved in Alzheimer's disease), calculated with 2 databases: An analogue database consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over; A digital database, consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over	1 hour