Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research

Not Applicable

• Conditions: Magnetic Resonance Imaging Sequences
• Interventions: Device: MRI acquisitions

• Registration Number: NCT03674645
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

Detailed Description

The purpose of the present study is to test and optimize, on healthy subjects, specific MRI acquisition sequences firstly developed in a preclinical phase on phantoms (inert objects containing solutions or gels) and animal (Pig, sheep). This study will allow the investigators to define practical acquisition parameters that will allow reproducible results and precise definition of clinically relevant examination protocols for each new developed sequence.

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2018-09-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Healthy volunteers (over 18 yo),
• Male or female,
• Affiliated to social security,
• Without any contraindication to MRI exam and who will have signed a written inform consent.

Exclusion Criteria

• Individuals deprived of liberty,
• Under guardianship or curatorship,
• Persons with known disease which could disturb MRI acquisition or with absolute or relative contraindication to an MRI examination
• Pregnant women,
• Breastfeeding women,
• Women without effective contraception,
• Participants who refused to be informed of the possible discovery of a significant anomaly,
• Persons involved in an interventional study with a drug or an implantable device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	MRI acquisitions	MRI exam performed on 200 healthy volunteers

Primary Outcome Measures

Name	Time	Method
Image quality	Day 0
Qualitative interpretation of image quality to respiratory and cardiac motions	Day 0	In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The qualitative interpretation of image quality will be performed by visual image analysis.
Signal to noise ratio	Day 0
Total acquisition time	Day 0
Contrasts between structurally different regions	Day 0	The values of the signal intensities will be measured in adjacent structures of interest. The difference between these values divided by the noise will be calculated to quantify the contrast-to-noise ratio between these structures. The higher this value is, the better is the sequence in its ability to differentiate these structures from one another.
Quantitative interpretation of image quality to respiratory and cardiac motions	Day 0	In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The quantitative interpretation of image quality will be performed by a measurement of sharpness of contours between adjacent structures of interest.

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Pessac, France