- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01324206
Développement de méthodes de recherche par résonance magnétique 3T pour les études NIA
Background:
- Magnetic resonance imaging (MRI) studies provide important information on the structure and function of various body systems, including the brain, muscles, joints, heart, and blood vessels. Scientific applications of MRI scans often use techniques that need to be modified or refined before they are used in clinical studies. To develop and modify these techniques for the new Philips 3T Achieva whole-body MRI scanner, researchers are interested in conducting trial MRI scans on healthy individuals and individuals with conditions that require imaging studies.
Objectives:
- To conduct preliminary trials of the 3T MRI facility to develop and refine MRI scanning procedures.
Eligibility:
- Individuals at least 18 years of age who are able to have magnetic resonance imaging.
Design:
- Participants will be screened with a full medical history and physical examination, as well as blood and urine tests.
- Participants will have an MRI scan using the 3T scanner. Some scans may require the use of a contrast agent or radiotracer, which is a small amount of radioactive substance that will be injected before the start of the scan. Some participants may be asked to perform tasks of thinking and movement while in the scanner, in order to test the procedures required for a functional MRI scan.
- No treatment will be provided as part of this protocol.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Study Description:
The purpose of this protocol is to permit use of the magnetic resonance imaging (MRI) facility for the development and refinement of MRI and spectroscopy (MRIS) scanning procedures. The information obtained through these methodological assessments will be essential future clinical research investigations conducted through the NIA under specific protocols. Additionally, this data can be utilized in already approved NIA studies for comparison purposes.
Objectives:
Primary Objective: To develop and refine specific MR imaging and spectroscopy methods.
Secondary Objectives: To allow pilot tests of procedures for development and refinement of motor or cognitive activation paradigms.
Endpoints:
Development of noninvasive MR biomarkers to assess longevity, healthy longevity, physical disability, cognitive impairment, and frailty.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mustapha Bouhrara, Ph.D.
- Numéro de téléphone: (410) 558-8541
- E-mail: bouhraram@mail.nih.gov
Sauvegarde des contacts de l'étude
- Nom: Seung-Ho Park, R.N.
- Numéro de téléphone: (410) 350-7315
- E-mail: sarah.park@nih.gov
Lieux d'étude
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-
Maryland
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Baltimore, Maryland, États-Unis, 21224
- Recrutement
- National Institute of Aging, Clinical Research Unit
-
Contact:
- NIA Studies Recruitment
- Numéro de téléphone: 410-350-3941
- E-mail: niastudiesrecruitment@mail.nih.gov
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Healthy volunteers, male and female, 18yrs and older
La description
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all the following criteria:
- Ability of subject to understand the study and stated willingness to comply with all study procedures.
- Male or female, age > 18years.
- Able to speak and read English.
- Capable of providing informed consent.
- Subjects or persons identified by an investigator to have a condition of interest for exploratory studies as it relates to aging. These participants are not being scanned for diagnostic purposes.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Has condition and/or non-removable device contraindicated for MRI as per the MRI eligibility form.
- Weight > 300lbs (MRI scanner weight limit)
- Is currently pregnant or a nursing mother.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Healthy Volunteers
Healthy Volunteers, 18 or older years |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Develop and refine scanning procedures
Délai: 2 months
|
To develop and refine specific imaging and spectroscopic methods. |
2 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mustapha Bouhrara, Ph.D., National Institute on Aging (NIA)
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
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
Autres numéros d'identification d'étude
- 080238
- 08-AG-0238
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Informations sur les médicaments et les dispositifs, documents d'étude
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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 .