Constitution of a Standardized Neural Imaging Database in Healthy Subjects

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Completed
• CT.gov ID: NCT00484523
• Collaborator: (none)
• Enrollment: 60
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Procedure: SPET, PET and MRI	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• 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: Jul 1, 2007
• Actual Primary Completion Date: Jan 1, 2010

Outcome Measures

Primary Outcome Measures

1. precise brain morphology [two days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: 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:

• pregnancy

• breast feeding

• contraindication to MRI, SPET or PET exploration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Timone	Marseille		France	13385

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Principal Investigator: Eric GUEDJ, AHU, Assistance Publique des Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT00484523
• Other Study ID Numbers: 2007/09
• First Posted: Jun 11, 2007
• Last Update Posted: Aug 28, 2014
• Last Verified: Aug 1, 2014

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

Study Results

No Results Posted as of Aug 28, 2014