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CompletedNCT00484523Updated Aug 28, 2014

Constitution of a Standardized Neural Imaging Database in Healthy Subjects

An Early Phase 1 interventional study of SPET, PET and MRI in Healthy, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-28.

Sponsored by Assistance Publique Hopitaux De Marseille · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
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Study summary

MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric study, tissue study, study of connectivity).

Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).

These examinations routinely contribute to the clinical diagnosis and surveillance of many neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular pathology, brain tumors, etc.).

As a result of the original morphological and functional information they provide, these examinations are being increasingly included in clinical research protocols involving the brain.

The absolute or relative quantification of anomalies observed, however, can be obtained only after comparison to a database of normal subjects.

The creation of these databases is currently limited by their cost and strictly single center nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).

The aim of this multidisciplinary study is to constitute a standardized database of multimode neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in patients, at the scale of a group or an individual, for the diagnosis and surveillance of neurological diseases.

Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).

The strictly single center character of this study is explained by the variability of the physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to each center.

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Conditions studied

  • Healthy

Keywords

  • To constitute a standardized database of multimode neural imaging.
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In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • no neurological or psychiatric history
  • no serious disease
  • receiving no neurotropic
  • no alcoholism
  • no drug addiction
  • social security cover
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • breast feeding
  • contraindication to MRI, SPET or PET exploration
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Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Interventions

  • ProcedureSPET, PET and MRI

    60 healthy subjects after a a consultation with a neurologist for wich 4 examinations will be programmed in two days ( 1 cerebral MRI, 1pet scan, 1 spet, 1 datascan

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What researchers measure

Primary outcomes

  1. precise brain morphology

    Time frame: two days

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Study locations

1 site
  • CHU Timone
    Marseille, 13385, France
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References and documents

Publications

  • Mairal E, Barberon B, Laine N, Coulange M, Guedj E. Reversible widespread brain 18F-FDG PET hypometabolism in chronic fatigue syndrome treated by hyperbaric oxygen therapy. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1680-1681. doi: 10.1007/s00259-020-05122-0. Epub 2021 Jan 9. No abstract available. PubMed 33420913 ↗
  • Didic M, Felician O, Gour N, Bernard R, Pecheux C, Mundler O, Ceccaldi M, Guedj E. Rhinal hypometabolism on FDG PET in healthy APO-E4 carriers: impact on memory function and metabolic networks. Eur J Nucl Med Mol Imaging. 2015 Sep;42(10):1512-21. doi: 10.1007/s00259-015-3057-y. Epub 2015 Apr 22. PubMed 25900275 ↗
  • Arthuis M, Micoulaud-Franchi JA, Bartolomei F, McGonigal A, Guedj E. Resting cortical PET metabolic changes in psychogenic non-epileptic seizures (PNES). J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1106-12. doi: 10.1136/jnnp-2014-309390. Epub 2014 Dec 2. PubMed 25466258 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00484523
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jun 11, 2007
Start date
Jul 2007
Primary completion
Jan 2010
Last update
Aug 28, 2014

Study contacts

Eric GUEDJ, AHU
principal investigator · Assistance Publique des Hôpitaux de Marseille
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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