Creation of a Database of Healthy Subjects With 18FDG PET Brain Imaging as Part of the MOBILE Project (Multimodal Whole-Brain Imaging in Epilepsy)

NCT06976788 | Recruiting

• 1 other identifier: RCAPHM22_0171
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The MOBILE project is part of the dynamic European collaboration of the Human Brain Project (HBP). The overall aim of the project is to characterize brain structure and function in healthy subjects and patients with epilepsy, using a quantitative multimodal approach involving both neuroimaging (MRI, PET) and electrophysiology (EEG/MEG). The project is funded by the European HBP consortium, and the data acquired will ultimately be made available to the scientific community formed by this international collaboration. Several aspects of the project have already been initiated on the basis of extensions to previous authorizations, or as part of care activities. As part of this overall project, the present MOBILE-PET application concerns exclusively the performance of 18F-FDG PET (Positron Emission Tomography) imaging in the 30 healthy adult subjects in the protocol (aged 18 to 65, with inclusion parity for gender). This cerebral examination, performed at rest on a 45-minute 3D volume acquisition, enables quantitative measurement of the metabolic consumption of glucose underlying global synaptic activity, and to determine the associated connectivity. Around 1,500 examinations of this type are carried out each year in our department as part of care for patients with brain pathology, and over 10,000 for patients with cancer. This examination requires intravenous injection of a weakly radioactive tracer corresponding to a radiopharmaceutical which has been approved for marketing for over 20 years. We also carried out and finalized a similar project in 2007 on 60 healthy subjects, using a previous-generation PET camera (NCT00484523). The Nuclear Medicine Department holds clinical research authorizations for imaging in patients and healthy subjects (including early phase and first-in-man, although the present project does not fall into this research categarogy).

Conditions

Healthy; Tomography; Brain Development

Outcome Measures

Primary Outcomes (1)

• cerebral glucose consumption

  Baseline and 24 months (longitudinal follow-up)

Secondary Outcomes (1)

• Metabolic connectivity

  Baseline and 24 months (longitudinal follow-up)

Study Arms (1)

Whole-Brain Imaging

OTHER

Other: Tomography exam

Interventions

Tomography exam OTHER

Brain imaging examination

Whole-Brain Imaging

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Female or male, over 18 and under 65 years of age.
• Subject free of any general illness, psychiatric disorders or infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology of the central nervous system, as determined on examination,
• Subject not receiving chronic treatment, particularly psychotropic,
• Subject with no history of alcoholism or drug addiction,
• Subject with no contraindications to PET scintigraphic exploration (pregnancy and breast-feeding),
• Subject with social security coverage,
• Subject having read, understood and signed an informed consent form.

You may not qualify if:

• \- Minors,
• Pregnant or breast-feeding women,
• Women of childbearing age without contraception,
• Subjects presenting a contraindication to PET scintigraphic exploration,
• adult subject to a legal protection measure, as provided for in L.1121-6 to L.1121-8 of the French Public Health Code.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hopital de la Timone

Marseille, 13354, France

RECRUITING

Central Study Contacts

Eric GUEDJ, MD

CONTACT

0491386595; eric.guedj@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: May 16, 2025
• Study Start: September 26, 2024
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: May 16, 2025

Record last verified: 2024-09

Locations

FR (1)