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NCT Number: NCT06494228

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Radiologie II, CHU de Strasbourg

Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 67091, France

Location status: Recruiting

Location contact

Elies KNAUB, MD

SUB_INVESTIGATOR

François-Daniel ARDELLIER, MD

CONTACT

[email protected]

33 3 68 76 53 37

François-Daniel ARDELLIER, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

François-Daniel ARDELLIER, MD

CONTACT

[email protected]

33 3 68 76 53 37

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: Optic-Neuritis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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