- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04866940
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: VAYSSIERE Nathalie, PhD
- Telefonnummer: +33562746132
- E-post: nathalie.vayssiere@cnrs.fr
Studer Kontakt Backup
- Navn: DAGNAC Helene, PhD
- Telefonnummer: +33562746122
- E-post: helene.gros@inserm.fr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
in general
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: ¨PAYOUX Pierre, Pr, Institut National de la Santé Et de la Recherche Médicale, France
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- C20-28
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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