- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01324206
Desarrollo de métodos de investigación de resonancia magnética 3T para estudios 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mustapha Bouhrara, Ph.D.
- Número de teléfono: (410) 558-8541
- Correo electrónico: bouhraram@mail.nih.gov
Copia de seguridad de contactos de estudio
- Nombre: Seung-Ho Park, R.N.
- Número de teléfono: (410) 350-7315
- Correo electrónico: sarah.park@nih.gov
Ubicaciones de estudio
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-
Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Reclutamiento
- National Institute of Aging, Clinical Research Unit
-
Contacto:
- NIA Studies Recruitment
- Número de teléfono: 410-350-3941
- Correo electrónico: niastudiesrecruitment@mail.nih.gov
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Healthy volunteers, male and female, 18yrs and older
Descripción
- 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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_ONLY
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Healthy Volunteers
Healthy Volunteers, 18 or older years |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Develop and refine scanning procedures
Periodo de tiempo: 2 months
|
To develop and refine specific imaging and spectroscopic methods. |
2 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mustapha Bouhrara, Ph.D., National Institute on Aging (NIA)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 080238
- 08-AG-0238
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .