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

Brain Diseases Clinical Trial

— ATLATEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05355857
• Other study ID #: 2021-008
• Status: Completed
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: April 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases

Intervention

Diagnostic Test:
• brain PET-MRI with 18F-FDG
Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	ICube Laboratory

Country where clinical trial is conducted

France, 

Outcome

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