- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02058043
Study of MRI 3Tesla Infusion Without Arterial Spin Labeling Injection (ASL) in Cognitive Atypical and Comparison to the FDG-PET (ASLDEM DS)
Study of MRI 3 Tesla Using Arterial Spin Labeling (Without Infusion) in Cognitive Atypical Disorders and Comparison to FDG-PET
DESCRIPTION OF RELATED QUESTION Cognitive disorders are frequently encountered and present a major public health problem given the aging of the population.
There is not one, but several neurodegenerative pathologies individual differentiated.
Particularly distinguished is Alzheimer's disease (the most common), dementia lobar fronto-temporal associated with semantic dementia (a disease with a particular tropism for semantic memory and the anterior temporal lobe), and dementia with Lewy bodies.
To differentiate these pathologies is, for the clinician, is a major issue and the clinic may not be enough.
The management and current diagnostics of atypical cognitive disorders, that is to say, patients with clinical symptoms or neuropsychological testing results suggestive of a neurodegenerative disorder other than Alzheimer's disease, are based largely on data imaging.
In the first intention, conducting imaging by MRI is recommended by the HAS, particularly to search for treatable causes to these cognitive disorders (tumors, intracranial hemorrhage in particular) but also to study the distribution of cerebral atrophy.
The sequences used are the sequences 3D T1, axial Flair, gradient echo axial T2 and coronal T2 in the plane of hippocampi and also diffusion imaging.
Research has shown interest in the study of cerebral perfusion in cognitive disorders.
The HAS recommends not to inject contrast medium on MRI in this context. The sequence of perfusion by tagging arterial protons or "arterial spin labeling" (ASL) does not use exogenous contrast medium. This is available as a commercial product, CE marked, on most of the recent clinical MRI scanners. This non-invasive technique, requiring no special precautions (e.g. verification of renal function) is used in routine clinical practice at the University Hospital of Rennes and in many centers. In the imaging of patients with dementia, it is widely used as well as the 3D T1 sequences or diffusion imaging (International Initiative ADNI) and is subject to optimization and harmonization of use in routine clinical practice with the European COST AID actions.
The second intention, an isotope imaging by FDG-PET or study of perfusion SPECT can also be performed. The interest of isotopic imaging (FDG-PET and SPECT) lies in the provision of information metabolic nonexistent in MRI, with a superiority of FDG-PET compared with SPECT. FDG-PET is the preferred examination and is carried out at CRLCC Eugène Marquis de Rennes in this context.
The aim of our study is to compare the imaging of TEPFDG, a technique not morphological, and ASL that, even if they do not study the same mode (metabolism for the first and perfusion for the second) may depict consistent anomalies.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
IV
-
Rennes, IV, France, 35033
- CHU de Rennes
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Male and females over 18 years of age
- Patients presenting with atypical cognitive disorders, clinically and through neuropsychological tests, justifying the prescription by a specialist doctor of a brain MRI and FDG-PET and lie within the context of the recommendations of the HAS.
- Patients who have received the protocol information and who given their written informed consent.
Exclusion Criteria:
Contra-indications of MRI
- Pacemaker or implantable defibrillator,
- Neurosurgical clips,
- Cochlear implants,
- Intra orbital or encephalic metallic foreign bodies,
- Endoprostheses less than 4 weeks old and osteosynthesis material used within the last 6 weeks,
- Claustrophobia. Contra-indication of FDG-PET
- Pregnancy
- Nursing mothers
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
detection of hypoperfusions
Délai: less than 6 weeks
|
The detection of hypoperfusions with ASL will be performed after quantification of cerebral blood flow by comparison to a template of healthy subjects of the same age. A base of imaging data in healthy subjects has already been acquired under another project. Some of this imaging data will be used as comparison data. No healthy subject will be included in the study ASLDEM-DS. |
less than 6 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2012-A00147
- LOC1202 Gauvrit ASLDEM DS (Autre identifiant: Rennes University Hospital)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Atypical Cognitive Disorders
-
Foundation University IslamabadRecrutementDysfonctionnement cognitif | Déclin cognitif | Trouble cognitifPakistan
-
National Taiwan University HospitalNational Taiwan Science Education Center(NTSEC)ComplétéEntraînement cognitif | Déclin cognitif subjectifTaïwan
-
Foundation University IslamabadRecrutementDéclin cognitif | Trouble cognitif | Troubles cognitifsPakistan
-
China Medical University HospitalPas encore de recrutementDéclin cognitif subjectif | Déclin cognitif subjectif (SCD)Taïwan
-
Rotman Research Institute at BaycrestRecrutementTrouble cognitif léger (MCI) | Déclin cognitif subjectif (SCD)Canada
-
University of Social Sciences and Humanities, WarsawNational Science Centre, Poland; Sanprobi Sp. z o. o.Actif, ne recrute pasDéclin cognitif | Vieillissement cognitif | Déclin de la mémoirePologne
-
Rotman Research Institute at BaycrestSunnybrook Health Sciences Centre; University of Waterloo; Toronto Rehabilitation... et autres collaborateursRésiliéDéclin cognitif subjectif | Déclin cognitif lié à l'âgeCanada
-
University of MiamiComplété
-
The Hong Kong Polytechnic UniversityRecrutementDéclin cognitif subjectifChine
-
University Hospital TuebingenPas encore de recrutementDéclin cognitif subjectifAllemagne