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RecruitingNCT06494228Optic-NeuritisUpdated Jul 10, 2024

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

An observational study in Multiple Sclerosis and Demyelinating Diseases, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis
  • Demyelinating Diseases

Keywords

  • Multiple Sclerosis
  • Demyelinating Diseases
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Comparison of the radiologist's degree of diagnostic confidence based on the three sequences (3D FLAIR, 3D DIR and 3D PSIR sequences).

    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.

    Time frame: One month after brain MRI

07

Study locations

1 of 1 sites recruiting
  • Service de Radiologie II, CHU de Strasbourg
    Strasbourg, Les Hôpitaux Universitaires De Strasbourg 67091, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06494228
Responsible party
Sponsor
First posted
Jul 10, 2024
Start date
Jan 19, 2024
Primary completion
Jan 2025 (estimated)
Completion
Jan 19, 2025 (estimated)
Last update
Jul 10, 2024

Study contacts

François-Daniel ARDELLIER, MD
Contact
francois-daniel.ardellier@chru-strasbourg.fr
33 3 68 76 53 37

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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