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Evaluation of New MRI Sequences Including 3D-FGAPSIR for the Optimization of Inflammatory Spinal Cord Lesions Research (ESPOIR2)

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: NCT04906928
Recruitment Status : Not yet recruiting
First Posted : May 28, 2021
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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Brief Summary:
  • verification of inclusion and non-inclusion criteria
  • information and collection of consent
  • standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
  • 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Condition or disease Intervention/treatment
Spinal Cord Injuries Device: MRI

Detailed Description:
  • verification of inclusion and non-inclusion criteria
  • information and collection of consent
  • standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
  • 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Performance of a 3D FGAPSIR Sequence by MRI in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: MRI
    • standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
    • 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Outcome Measures
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Primary Outcome Measures :
  1. estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence. [ Time Frame: 1 DAY ]
    estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence.


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:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be offered prospectively to patients presenting to the imaging department for a 3T MRI for bone marrow exploration, in the context of inflammatory involvement of the nevrax
Criteria

Inclusion Criteria:

  • Patient over 18 years old
  • To benefit from a medullary exploration planned by 3T MRI as part of a first evaluation or a reassessment of inflammatory involvement of the nevrax
  • Express consent to participate in the study
  • Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

  • Patient benefiting from a legal protection measure
  • Pregnant, parturient or breastfeeding woman
  • Absolute or relative contraindication to MRI
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04906928


Contacts
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Contact: amélie YAVCHITZ 0148036454 ayavchitz@for.paris

Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04906928    
Other Study ID Numbers: ALR_2021_15
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries