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OpenTrials
Completed

NCT Number: NCT05355857

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

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).

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Key information

Conditions

Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de cancérologie Strasbourg Europe

Strasbourg, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

brain PET-MRI with 18F-FDG

Diagnostic Test

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

Primary outcomes

  1. Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers

    Time frame: 30 minutes after 18F-FDG injection

    Evaluation of tracer activity at the cerebral level on the acquisition images

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Collaborators

  • ICube Laboratory

Registry information

Acronym: ATLATEP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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