NCT02900339

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

8.5 years

First QC Date

September 9, 2016

Last Update Submit

December 13, 2022

Conditions

Keywords

MRISequence optimizationHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Qualitative assessment of acquired sequences

    One day after data acquisitions

Study Arms (1)

MR parameters optimization

EXPERIMENTAL

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

Interventions

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.

Also known as: Magnetom
MR parameters optimization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiology Department CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jean-Christophe FERRE, MD, PhD

    CHU Rennes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 14, 2016

Study Start

April 18, 2013

Primary Completion

October 12, 2021

Study Completion

October 12, 2021

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations