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

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ClinicalTrials.gov Identifier: NCT02900339
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: Magnetic Resonance Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI Sequences Optimization in Healthy Subjects
Study Start Date : April 2013
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

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 Name: Magnetom




Primary Outcome Measures :
  1. Quantitative assessment of acquired sequences [ Time Frame: One day after data acquisitions ]

    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...



Secondary Outcome Measures :
  1. Qualitative assessment of acquired sequences [ Time Frame: One day after data acquisitions ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900339


Contacts
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Contact: Jean-Christophe FERRE, MD, PhD jean-chrisophe.ferre@chu-rennes.fr
Contact: Anne HESPEL, PhD anne.hespel@chu-rennes.fr

Locations
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France
Radiology Department CHU de Rennes Recruiting
Rennes cedex 9, France, 35033
Contact: Anne HESPEL, PhD    2 99 28 25 55    drc@chu-rennes.fr   
Principal Investigator: Jean-Christophe FERRE, MD, PhD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Study Director: Jean-Christophe FERRE, MD, PhD CHU Rennes

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02900339     History of Changes
Other Study ID Numbers: 35RC11_8965
2011-A01531-40 ( Other Identifier: Id-RCB )
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rennes University Hospital:
MRI
Sequence optimization
Healthy volunteers