Constitution of a Standardized Neural Imaging Database in Healthy Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00484523
First received: June 8, 2007
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Healthy
Procedure: SPET, PET and MRI
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Constitution of a Standardized Neural Imaging Database in Healthy Subjects

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • precise brain morphology [ Time Frame: two days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484523

Contacts
Contact: Eric GUEDJ, AHU + 33 4 91 38 55 58 eric.guedj@ap-hm.fr

Locations
France
CHU Timone Recruiting
Marseille, France, 13385
Contact: Eric GUEDJ, AHU    + 33 4 91 38 55 58    eric.guedj@ap-hm.fr   
Sub-Investigator: Olivier MUNDLER, PU-PH         
Sub-Investigator: Bertrand AUDOIN, CCA         
Sub-Investigator: Nadine GIRARD, PU-PH         
Sub-Investigator: Patrick CHAUVEL, PU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Eric GUEDJ, AHU Assistance Publique des Hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: le bras, assistance Publique Hopitaux de Marseille
ClinicalTrials.gov Identifier: NCT00484523     History of Changes
Other Study ID Numbers: 2007/09
Study First Received: June 8, 2007
Last Updated: January 26, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique Hopitaux De Marseille:
To constitute a standardized database of multimode neural imaging.

ClinicalTrials.gov processed this record on August 19, 2014