Constitution of a Standardized Neural Imaging Database in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT00484523|
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : August 28, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Procedure: SPET, PET and MRI||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Constitution of a Standardized Neural Imaging Database in Healthy Subjects|
|Study Start Date :||July 2007|
|Primary Completion Date :||January 2010|
Procedure: SPET, PET and MRI
- precise brain morphology [ Time Frame: two days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484523
|Marseille, France, 13385|
|Principal Investigator:||Eric GUEDJ, AHU||Assistance Publique des Hôpitaux de Marseille|