OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers

Not Applicable

• Conditions: Healthy
• Interventions: Device: MRI data acquiring in healthy volunteers

• Registration Number: NCT03440983
• Lead Sponsor: Rennes University Hospital

Brief Summary

Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the examination. The study is interventionnal because healthy volunteers are not supposed to have an MRI exam.

The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.

The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.

Detailed Description

Using MRI, many technical parameters (sequence, parameters in the sequence, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the examination.

The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.

The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.

Prospective, single-center, observational MRI study A screening visit is planned to check the inclusion/non inclusion criteria followed by an imaging visit during which the MRI examination will be performed.

Theses 2 visits are scheduled at the subject's convenience. The number of participations to the study is limited to 5 per year per subject.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-08
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-22
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female subject,
• Aged 18 or above

Exclusion Criteria

• Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
• Claustrophobic patient
• Pregnancy
• Breastfeeding
• Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
• No healthcare insurance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI data acquiring in healthy volunteers	MRI data acquiring in healthy volunteers	MRI data acquiring in healthy volonteers

Primary Outcome Measures

Name	Time	Method
MRI data acquisition : quality of the images, cartographies or spectres	0.5 day	The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools

Trial Locations

Locations (1)

Radiology Department CHU de Rennes; 🇫🇷 Rennes cedex 9, France