Validation and Implementation of 3T MRI Research Protocols (VALIDIRM)
The Philips 3T imager installed on the Pavillon Baudot site is an imager dedicated solely to research. It is not located in hospital premises but in INSERM premises for which an authorization for biomedical research has been granted. This equipment is part of the Technical Platform of the UMR 1214 ToNIC whose main objective is the study of the human brain and the main pathologies that affect it.
MRI is an evolving technique, which is used in many research projects. Our technical platform must follow these developments and remain at the cutting edge. One of the essential services of our technical platform is to help set up research protocols and validate acquisition sequences. This development activity is therefore located upstream of research projects involving clinical or fundamental applications. The fact that we can provide our users with a regulatory framework to carry out these development tests for their Research Involving Human Subjects project is a necessity for our research support activity.
This study aims to provide a generic framework to test the feasibility of MRI sequences requested within the framework of protocols, but also to optimize MRI acquisition sequences already in place, to improve image quality and reduce artifacts that can degrade the quality of the images obtained.
In France, there are just over 35 centers with MRI dedicated to research and therefore with a validation protocol allowing them to validate their sequences.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective monocentric research on major participants (healthy and patients). The optimization of the sequences will be carried out in an incremental way from one control to the other: for each control, several sequences will be carried out for an acquisition time not exceeding one hour of cumulated acquisition (i.e. one hour and a half including the installation and the delays between the sequences). Each sequence lasts between 5 and 20 minutes.
At the end of the examination, the images obtained will be evaluated jointly by an expert neuroradiologist and a research engineer specialized in image analysis according to the criteria mentioned above. This analysis will make it possible to determine the parameters to be modified to improve image quality and to define the acquisition parameters for the next test.
As soon as a sequence is considered optimal, it will be tested on a small number of healthy controls (≈ 5) to ensure interindividual reproducibility of image quality parameters, and then if necessary in the presence of pathology in a few patients (≈ 5).
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: VAYSSIERE Nathalie, PhD
- Número de teléfono: +33562746132
- Correo electrónico: nathalie.vayssiere@cnrs.fr
Copia de seguridad de contactos de estudio
- Nombre: DAGNAC Helene, PhD
- Número de teléfono: +33562746122
- Correo electrónico: helene.gros@inserm.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female, 18 years of age or older
- Ability to cooperate and remain motionless for up to 1 hour (and lying down for 1.5 hours)
- Ability to understand the instructions given
- Subject who has given written and informed consent prior to any examination required by the research)
- Subject affiliated to a social security system or benefiting from an equivalent system
Exclusion Criteria:
- Persons deprived of liberty by judicial or administrative decision
- Psychiatric disorders, disorders of cognitive functions, not allowing the realization of the MRI
- Protected adults (subject to a measure of legal protection) or unable to express their consent
- Subject with Contraindications to MRI
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Sequence validation
This research aims to provide a generic framework to test the feasibility of MRI sequences requested as part of protocols, but also to optimize MRI acquisition sequences already in place, to improve image quality and reduce artifacts that can degrade the quality of images obtained.
|
the realization of preliminary acquisitions to validate the feasibility of clinical or cognitive research protocols
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
in general
Periodo de tiempo: at the end of studies ((i.e. one hour and a half including the installation and the delays between the sequences). Each sequence lasts between 5 and 20 minutes.
|
optimization of parameters acquisition in order to suppress artefact
|
at the end of studies ((i.e. one hour and a half including the installation and the delays between the sequences). Each sequence lasts between 5 and 20 minutes.
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: ¨PAYOUX Pierre, Pr, Institut National de la Santé Et de la Recherche Médicale, France
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Otros números de identificación del estudio
- C20-28
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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