Magnetic Resonance Imaging (MRI) Sequences Optimization in Healthy Subjects

Healthy Volunteers Clinical Trial

— OSS-IRM  

Official title:

MRI Sequences Optimization in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900339
• Other study ID #: 35RC11_8965
• Secondary ID: 2011-A01531-40
• Status: Completed
• Phase: N/A
• Start date: April 18, 2013
• Est. completion date: October 12, 2021

Study information

• Verified date: December 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
France	Radiology Department CHU de Rennes	Rennes cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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