OSV-IRM - Volunteer MRI Sequence Optimization

Not Applicable

Recruiting

• Conditions: MRI
• Interventions: Other: MRI

• Registration Number: NCT05107232
• Lead Sponsor: Rennes University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-31
• Status Verified: 2021-11
• Study Start: 2021-11-04
• Study First Posted: 2021-11-04
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-12
• Primary Completion: 2026-11
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	MRI	Patients and Healthy volunteers included will have an MRI

Primary Outcome Measures

Name	Time	Method
Quality of MRI signal	15 days	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.).

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France