Optimization of the Acquisition Sequence to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam

Healthy Subjects Clinical Trial

— AIMANT  

Official title:

Optimization of the Acquisition Sequence to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645628
• Other study ID #: 2020-A01969-30
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: December 3, 2025

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: Valérie LAURENT, MD, PhD
• Phone: +33383154181
• Email: v.laurent[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the optimization of MRI acquisition sequences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: December 3, 2025
• Est. primary completion date: December 3, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for all subjects :

• to be over 18 year-old,

• to be able to understand the instructions given,

• to be enrolled in a social security plan,

• to have underwent a pre-inclusion medical examination,

• to give a written consent.

Inclusion Criteria especially for Patients :

• to perform a MRI examination of the head, neck, spine, thorax, abdomen, pelvis, retroperitoneum, lower limbs, upper limbs or whole body during clinical follow-up care.

Exclusion Criteria for all subjects :

• any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ),

• subject under a measure of legal protection.

Exclusion Criteria especially for Healthy Subjects :

• to have a pathology in the anatomical area to be imaged

• to be employed by the CHRU of Nancy or having the slightest link of subordination with the CHRU of Nancy.

Exclusion Criteria especially for Patients :

• to have a limited MRI examination time due to a sensitive clinical situation (sedation, unstable hemodynamic state, postoperative).

Related Conditions & MeSH terms

• Healthy Subjects
• Patient Performing an MRI Examination

Intervention

Other:
• MRI examination
All subjects (healthy subjects and patients) will have an MRI examination with optimized sequences

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality based on standard imaging quality criteria.	The image quality will be appreciated visually at least by a radiologist or a researcher.	6 months after the last inclusion
Secondary	Comparison of the Signal to Noise Ratio obtained by the optimized MRI sequence and the reference situation (standard sequence).	Signal to Noise Ratio will be measured in arbitrary units.	6 months after the last inclusion
Secondary	Comparison of the Contrast to Noise Ratio obtained by the optimized MRI sequence and the reference situation (standard sequence).	Contrast to Noise Ratio will be measured in arbitrary units.	6 months after the last inclusion
Secondary	Comparison of the acquisition time obtained with the optimized MRI sequence and the reference situation (standard sequence).	Time acquisition will be evaluated in minutes.	6 months after the last inclusion
Secondary	Comparison of blurring and artefacts obtained by the optimized MRI sequence and the reference situation (standard sequence).	Absence of blurring and artefacts will be assessed by at least one radiologist according to an ordinal scale.	6 months after the last inclusion
Secondary	Comparison of the spatial resolution obtained by the optimized MRI sequence and the reference situation (standard sequence).	Spatial resolution will be measured in mm².	6 months after the last inclusion
Secondary	Qualification of the MRI acquisition for a clinical study.	Validation of MRI acquisition by a centralized review center.	6 months after the inclusion
Secondary	Evaluation of intra-subject reproducibility on the same MRI and on two MRIs.	Measurement of intra-subject reproducibility on the same MRI and on two MRIs by the intra-class correlation coefficient for quantitative measurement or by the kappa coefficient for a qualitative measurement.	6 months after the last inclusion