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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 : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date September 17, 2018
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Image quality [ Time Frame: Day 0 ]
  • Signal to noise ratio [ Time Frame: Day 0 ]
  • 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.
  • Total acquisition time [ Time Frame: Day 0 ]
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research
Official Title  ICMJE Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Magnetic Resonance Imaging Sequences
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: MRI
MRI exam performed on 200 healthy volunteers
Intervention: Device: MRI acquisitions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674645
Other Study ID Numbers  ICMJE CHUBX 2017/21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)
Investigators  ICMJE
Principal Investigator: Hubert COCHET, MD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP