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

NCT ID: NCT06976788

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2026-09-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Whole-Brain Imaging

Group Type: OTHER

Tomography exam

Intervention Type: OTHER

Brain imaging examination

Interventions

Tomography exam

Brain imaging examination

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• - 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.

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital de la Timone

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric GUEDJ, MD

Role: CONTACT

eric.guedj@ap-hm.fr

0491386595

Facility Contacts

Eric Guedj

Role: primary

eric.guedj@ap-hm.fr

0491386595

Other Identifiers

RCAPHM22_0171

Identifier Type: -

Identifier Source: org_study_id