OSV-IRM - Volunteer MRI Sequence Optimization

MRI Clinical Trial

— OSV-IRM  

Official title:

OSV-IRM - Volunteer MRI Sequence Optimization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107232
• Other study ID #: 35RC21_8958_OSV-IRM
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• MRI

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