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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05107232
Other study ID # 35RC21_8958_OSV-IRM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 4, 2021
Est. completion date December 2027

Study information

Verified date November 2021
Source Rennes University Hospital
Contact Blandine Gautier
Phone 299282591
Email blandine.gautier@chu-rennes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Optimization of magnetic resonance imaging (MRI) protocols on healthy volunteers and voluntary patients. In MRI, a large number of technical parameters (sequence, parameters in sequence, antenna, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the exam. Some optimizations can be performed on participants healthy volunteers, others need to be carried out on images pathological and acquired in voluntary patients.


Description:

An inclusion visit is planned to verify the criteria for selection, then an imaging visit to perform the MRI examination. The imaging visit can take place at the end of the inclusion visit and until the following 15 days. For healthy volunteers, the visits are organized according to their availability. For patients, on the other hand, participation in the research will depend on the programming of the MRI within the framework care. This is a single-center prospective study carried out at two sites in the Rennes University Hospital.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 2027
Est. primary completion date November 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria: - Criteria common to all participants: - Minor or major subject - Affiliated, himself or through his parents if he is a minor, to a a social security scheme - Having given their free, informed and written consent, and/or which the free, informed and written consent of the holder(s) parental authority has been obtained for minors Specific criteria for healthy volunteers: o No medical or surgical history related to the anatomical area(s) scanned Specific criteria for voluntary patients: o Indication for an MRI exam as part of its management Exclusion Criteria: - - Contraindication to an MRI (pacemaker or pacemaker, neurostimulator, intra-orbital metal body, vascular clip ferromagnetic) - Pregnancy - Legal protection measure for adults in progress (safeguard of justice, guardianship, curatorship) or subject deprived of liberty

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MRI
MRI

Locations

Country Name City State
France CHU Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of MRI signal The quality of the images, maps or signals collected will be compared to standard acquisitions. This evaluation will be done by statistical comparison of visual qualitative criteria by expert radiologists or on quantitative criteria drawn from analyzes computing data obtained by processing experts images (signal-to-noise ratio, contrast-to-noise ratio, blur level, mutual information, co-location of regions highlighted by different techniques, etc.). 15 days
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