Constitution of a Standardized Neural Imaging Database in... | NCT00484523

Studies
Constitution of a Standardized Neural Imaging Database in Healthy Subjects

NCT00484523

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Aug 28, 2014Estimated

Enrollment

60Actual

Phase

Early Phase 1

Conditions

Healthy

Interventions

SPET, PET and MRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Not provided

First Submitted Date

Jun 8, 2007

First Submission Date that Met QC Criteria

Jun 8, 2007

First Posted Date

Jun 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2014

Last Update Posted Date

Aug 28, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPET, PET and MRI	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
precise brain morphology		two days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric GUEDJ, AHU	Assistance Publique des Hôpitaux de Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Timone		Marseille		13385	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33420913	Derived	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.
25900275	Derived

ID	Term
C062942	2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole
D009682	Magnetic Resonance Spectroscopy

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques