HealthyMOBILE-PETNCT06976788
Creation of a Database of Healthy Subjects With 18FDG PET Brain Imaging as Part of the MOBILE Project (Multimodal Whole-Brain Imaging in Epilepsy)
A study testing Tomography exam in people with Healthy and Tomography, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Tomography, Brain Development
- What is being tested?
- Tomography exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2024to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital de la Timone
Marseille, 13354
Eric Guedj, 0491386595, eric.guedj@ap-hm.fr
eric guedj, MD
About this study
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
- Being tested
- Tomography exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomography examOther
Brain imaging examination
| Study group | Role | What they receive |
|---|---|---|
| Whole-Brain Imaging | Other | Not described Receives: Other: Tomography exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral glucose consumption
Measured: Baseline and 24 months (longitudinal follow-up)
Secondary outcomes (1)
Metabolic connectivity
Measured: Baseline and 24 months (longitudinal follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start26 Sep 2024
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976788
- Sponsor's protocol ID
- RCAPHM22_0171
- Acronym
- MOBILE-PET
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Database of Healthy Subjects With 18FDG PET Brain Imaging as Part of the MOBILE Project (Multimodal Whole-Brain Imaging in Epilepsy)
- ClinicalTrials.gov ID
- NCT06976788
- Acronym / sponsor ID
- MOBILE-PET / RCAPHM22_0171
- Conditions
- Healthy, Tomography, Brain Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole-Brain Imaging | Other | Other: Tomography exam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - 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),
Key exclusion criteria (5 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomography examBrain imaging examination | Other | Whole-Brain Imaging |
Primary outcome
cerebral glucose consumption
Time frame: Baseline and 24 months (longitudinal follow-up)
1 secondary outcome
Metabolic connectivity
Time frame: Baseline and 24 months (longitudinal follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomography exam in people with Healthy and Tomography, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric GUEDJ, MD (0491386595, eric.guedj@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral glucose consumption (time frame: Baseline and 24 months (longitudinal follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.