Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.

Not Applicable

Completed

• Conditions: Brain Diseases
• Interventions: Diagnostic Test: brain PET-MRI with 18F-FDG

• Registration Number: NCT05355857
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief Summary

With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons.

Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).

Detailed Description

This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Study Start: 2022-08-10
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Male or female aged 20 to 50
• Absence of any history or cardiovascular, neurological or psychiatric deficit
• Signed the informed consent

Exclusion Criteria

• Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG
• People using a pacemaker or insulin pump
• People wearing a metal prosthesis or an intracerebral clip
• People with intraocular metal splinters
• People with a pathology considered incompatible for the production of the atlas according to the investigator
• Pregnant women and breastfeeding women
• Subject in period of exclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FDG injection	brain PET-MRI with 18F-FDG	Health volunteers with 18-F-FDG injection

Primary Outcome Measures

Name	Time	Method
Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers	30 minutes after 18F-FDG injection	Evaluation of tracer activity at the cerebral level on the acquisition images

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France