Magnetic Resonance Imaging (MRI) Sequences Optimization in Healthy Subjects (OSS-IRM)

MRI Sequences Optimization in Healthy Subjects

Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving.

Many advances in MRI require constant adaptations of radiological practices. The morphological image is now associated with functional and parametric information (infusion, diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing of data also open new applications (tractography, functional MRI, etc ....). Thus, more and more procedures are necessary to "integrate" these techniques for the diagnosis and adapt to new demands of clinicians.

The type of sequence and its associated parameters allow to directly influence the contrast of images, to characterize tissue compared to another and, ultimately, to highlight morphological or functional abnormality. Image quality can be optimized on each MRI, depending on the time available for the acquisition on the one hand, and on the desired resolution and contrast, on the other hand. For each sequence, it is therefore necessary to find a compromise that will optimize the diagnostic quality of the examination.

This optimization requires a phase focusing on healthy volunteers. It is therefore important that researchers and physicists could design on healthy volunteers, the best settings of all parameters for an image or spectrum. Indeed, it is always necessary to properly optimize every parameter choices before beginning a study of a cohort of patients.

In this context, the main objective of this study is to optimize sequences and imaging protocols to evaluate and validate the choice of parameters in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Magnetic Resonance Imaging

• Study Type: Interventional
• Enrollment (Actual): 628
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes cedex 9, France, 35033
    • Radiology Department CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women aged over 18 years
• Written informed consent given

Exclusion Criteria:

• contraindication to MRI :

  • Claustrophobia
  • morphotype not allowing access to MRI
  • Wear a metallic implant, such as:
  • Pacemaker (pacemaker)
  • Ferromagnetic surgical clips
  • Intra orbital metallic foreign bodies or encephalic
• Pregnancy
• Breastfeeding
• Adults under guardianship, trusteeship or safeguard justice
• No social Insurance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MR parameters optimization; The study will be conducted on the MRI of the Neurinfo platform, in the radiology department of the University Hospital of Rennes.	Device: Magnetic Resonance Imaging; MRI of the Neurinfo platform is an MRI 3 Tesla Magnetom Verio model, Siemens (Siemens Healthcare, Erlangen, Germany). This imager is marked for European Conformity (CE), ensuring compliance with European Union safety standards.; Other Names: Magnetom

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative assessment of acquired sequences	Quality images, maps or spectra acquired with optimized parameters will be compared to standard acquisitions. This evaluation will be based on quantitative criteria extracted from computer analysis of the data : signal to noise ratio, contrast-to-noise, blur level, information sharing, collocation of areas set evidenced by the different techniques, etc...	One day after data acquisitions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of acquired sequences	Quality images, maps or spectra acquired with optimized parameters will be compared to standard acquisitions. This evaluation will be based on statistical comparison of visual qualitative criteria by experts radiologists	One day after data acquisitions

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Director: Jean-Christophe FERRE, MD, PhD, CHU Rennes

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2013
• Primary Completion (Actual): October 12, 2021
• Study Completion (Actual): October 12, 2021

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Healthy volunteers; Sequence optimization
• Other Study ID Numbers: 35RC11_8965; 2011-A01531-40 (Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No