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

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

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.

Study Overview

• Status: Completed
• Conditions: Neurodegenerative Diseases
• Intervention / Treatment: Diagnostic test: 18F FDG PET exam

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Vandoeuvre-les-Nancy Cedex, France, 54511
    • University Hospital Of Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The population will be enrolled thank to a listing of patient available in nuclear médicine unit. This listing cntain patient who performed a 18F-FDG brain TEP in nuclear médicine unit between 2010 and 2019.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 20 patients without anomaly of brain metabolism	Diagnostic test: 18F FDG PET exam; All patients have received 18F-FDG PET/CT in nuclear medicine
Group 2; 20 patients with Alzheimer's disease	Diagnostic test: 18F FDG PET exam; All patients have received 18F-FDG PET/CT in nuclear medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: GIE NANCYCLOTEP
• Investigators: Study Chair: Verger Antoine, PhD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2008
• Primary Completion (Actual): June 6, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: database; neurodegenerative disease; digital brain PET exam
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2019PI238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No