Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T (ESPOIR1-5)

December 12, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

Inclusion visit (D0):

  • 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), o 3D STIR sequence.
  • 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Clermont-ferrand, France, 63000
        • CHU de Clermont-Ferrand
      • Lille, France, 59000
        • CHU de Lille
      • Lyon, France, 69002
        • Chu de Lyon
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild (FOR)
      • Paris, France, 75013
        • Hôpital Privé des Peupliers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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 1.5T MRI for bone marrow exploration, in the context of inflammatory involvement of the nevrax

Description

Inclusion Criteria:

  • Patient over 18 years old
  • To benefit from a medullary exploration planned by MRI 1.5T as part of a first evaluation or a re-evaluation 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimate the number of spinal cord injuries detected with the set of standard sequences (T1, T2 and STIR) that are not detected with the 3D PSIR sequence
Time Frame: 1 DAY
1 DAY
Estimate the number of active lesions taking the contrast after injection of gadolinium, with the 3D PSIR sequence which is not detected in the set of standard sequences (T1, T2 and STIR)
Time Frame: 1 day
1 day
Compare the diagnostic confidence expressed by the radiologist for the detection of spinal cord injuries with the 3D PSIR sequence compared to the set of standard sequences (T1, T2 and STIR)
Time Frame: 1 DAY
1 DAY
Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)
Time Frame: 1 DAY
1 DAY
Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)
Time Frame: 1 DAY
1 DAY
Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence
Time Frame: 1 DAY
1 DAY
Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence
Time Frame: 1 DAY
1 DAY

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

June 6, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALR_2020_40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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