Constitution of a Standardized Neural Imaging Database in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00484523
First received: June 8, 2007
Last updated: August 27, 2014
Last verified: August 2014

June 8, 2007
August 27, 2014
July 2007
January 2010   (final data collection date for primary outcome measure)
precise brain morphology [ Time Frame: two days ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00484523 on ClinicalTrials.gov Archive Site
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Constitution of a Standardized Neural Imaging Database in Healthy Subjects
Constitution of a Standardized Neural Imaging Database in Healthy Subjects

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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Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Procedure: SPET, 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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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January 2010   (final data collection date for primary outcome measure)

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:

  • pregnancy
  • breast feeding
  • contraindication to MRI, SPET or PET exploration
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00484523
2007/09
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Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
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Principal Investigator: Eric GUEDJ, AHU Assistance Publique des Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP