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

NCT ID: NCT05355857

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2023-03-23

Brief Summary

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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

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

Conditions

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Brain Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Healthy volunteers
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FDG injection

Health volunteers with 18-F-FDG injection

Group Type OTHER

brain PET-MRI with 18F-FDG

Intervention Type DIAGNOSTIC_TEST

Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers

Interventions

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brain PET-MRI with 18F-FDG

Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICube Laboratory

UNKNOWN

Sponsor Role collaborator

Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de cancérologie Strasbourg Europe

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2021-008

Identifier Type: -

Identifier Source: org_study_id

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