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Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research (SEQ-IRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674645
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief Summary:
Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Sequences Device: MRI acquisitions Not Applicable

Detailed Description:
The purpose of the present study is to test and optimize, on healthy subjects, specific MRI acquisition sequences firstly developed in a preclinical phase on phantoms (inert objects containing solutions or gels) and animal (Pig, sheep). This study will allow the investigators to define practical acquisition parameters that will allow reproducible results and precise definition of clinically relevant examination protocols for each new developed sequence.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: MRI
MRI exam performed on 200 healthy volunteers
 Device: MRI acquisitions
Procedure of the study is an MRI exam without any injection or invasive procedure, that will be performed on the Siemens Magnetom Aera imager of Liryc institute (L'Institut de RYthmologie et modélisation Cardiaque) (Xavier Arnozan site - Bordeaux)


Outcome Measures
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Primary Outcome Measures :
  1. Image quality [ Time Frame: Day 0 ]
  2. Signal to noise ratio [ Time Frame: Day 0 ]
  3. Contrasts between structurally different regions [ Time Frame: Day 0 ]
    The values of the signal intensities will be measured in adjacent structures of interest. The difference between these values divided by the noise will be calculated to quantify the contrast-to-noise ratio between these structures. The higher this value is, the better is the sequence in its ability to differentiate these structures from one another.

  4. Total acquisition time [ Time Frame: Day 0 ]
  5. Qualitative interpretation of image quality to respiratory and cardiac motions [ Time Frame: Day 0 ]
    In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The qualitative interpretation of image quality will be performed by visual image analysis.

  6. Quantitative interpretation of image quality to respiratory and cardiac motions [ Time Frame: Day 0 ]
    In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The quantitative interpretation of image quality will be performed by a measurement of sharpness of contours between adjacent structures of interest.


Eligibility Criteria
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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:

  • Healthy volunteers (over 18 yo),
  • Male or female,
  • Affiliated to social security,
  • Without any contraindication to MRI exam and who will have signed a written inform consent.

Exclusion Criteria:

  • Individuals deprived of liberty,
  • Under guardianship or curatorship,
  • Persons with known disease which could disturb MRI acquisition or with absolute or relative contraindication to an MRI examination
  • Pregnant women,
  • Breastfeeding women,
  • Women without effective contraception,
  • Participants who refused to be informed of the possible discovery of a significant anomaly,
  • Persons involved in an interventional study with a drug or an implantable device.
Contacts and Locations
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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): NCT03674645


Contacts
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Contact: Hubert COCHET, MD (0)557675613 ext +33 hubert.cochet@chu-bordeaux.fr
Contact: Lorena SANCHEZ BLANCO, MD (0)557623091 ext +33 lorena.sanchez-blanco@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Recruiting
Pessac, France, 33604
Contact: Hubert COCHET, MD    (0)557675613 ext +33    hubert.cochet@chu-bordeaux.fr   
Contact: Lorena SANCHEZ BLANCO    (0)557623091 ext +33    lorena.sanchez-blanco@chu-bordeaux.fr   
Principal Investigator: Hubert COCHET, MD         
Sub-Investigator: Bruno QUESSON         
Sponsors and Collaborators
University Hospital, Bordeaux
L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)
Investigators
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Principal Investigator: Hubert COCHET, MD University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03674645    
Other Study ID Numbers: CHUBX 2017/21
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Healthy volunteers
Test
Optimization