Comparison of Diagnostic Performances of 3D FLAIR, DIR and PSIR Sequences in Optic Neuritis (Optic-Neuritis)

July 2, 2024 updated by: University Hospital, Strasbourg, France

Ultimately improve the care of patients suffering from multiple sclerosis (1st cause of acquired non-traumatic disability in adults) and NMO spectrum diseases by using more efficient MRI sequences than the FLAIR sequence commonly used in detection of optic neuritis.

In the literature, many studies have already focused on comparing the sensitivity of detection of white matter demyelination plaques using FLAIR, PSIR or DIR sequences.

Some authors have shown better sensitivity of the PSIR sequence in the detection of demyelinating lesions of the marrow in multiple sclerosis compared to conventional sequences.

Others have shown better performance of the combined use of PSIR and DIR sequences compared to the FLAIR sequence in the detection of cortical lesions in multiple sclerosis.

However, in the context of optic neuritis, few comparative studies comparing these three sequences have been carried out:

A 2022 study showed better diagnostic sensitivity of optic neuritis of the DIR sequence compared to the FLAIR sequence.

A possible better diagnostic performance of a sequence not used in current practice in the detection of optic neuritis (PSIR and DIR sequences), would be possible to justify their use on a larger scale and ultimately improve patient care.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

Study Locations

  • France
    • Les Hôpitaux Universitaires De Strasbourg
      • Strasbourg, Les Hôpitaux Universitaires De Strasbourg, France, 67091
        • Recruiting
        • Service de Radiologie II, CHU de Strasbourg
        • Contact:
        • Principal Investigator:
          • François-Daniel ARDELLIER, MD
        • Sub-Investigator:
          • Elies KNAUB, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult subject (≥18 years old), suffering from multiple sclerosis or an NMO spectrum disease, and having received an MRI including 3D FLAIR, 3D DIR and 3D PSIR sequences between April 1, 2019 and November 30 2021.

Description

Inclusion Criteria:

  • Major subject (≥18 years old)
  • Subject suffering from multiple sclerosis or an NMO spectrum disease
  • Subject having received an MRI including 3D FLAIR, 3D DIR and 3D PSIR sequences
  • Brain MRIs of eligible subjects acquired between April 1, 2019 and November 30, 2021.
  • No opposition to the reuse of its data for scientific research purposes.

Exclusion Criteria:

  • Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
  • Artifacts not allowing satisfactory interpretation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the radiologist's degree of diagnostic confidence based on the three sequences (3D FLAIR, 3D DIR and 3D PSIR sequences).
Time Frame: One month after brain MRI

During their analysis, each investigator fills out an interpretation grid for each series, where they indicate the presence or absence of optic neuritis and the degree of confidence they attribute to it on a scale of 1 to 5.

During their analysis, each investigator fills out an interpretation grid for each series, where they indicate the presence or absence of optic neuritis and the degree of confidence they attribute to it on a scale of 1 to 5.

A score of 5 shows that the level of confidence is very good.
One month after brain MRI

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

January 19, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 19, 2025

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9024 (VA - Health Services R&D)

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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