Comparison of Diagnostic Performances of 3D FLAIR, DIR an... | NCT06494228

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

NCT06494228

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Jul 10, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Multiple Sclerosis
Demyelinating Diseases

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2024Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Jan 19, 2025Estimated

First Submitted Date

Jul 2, 2024

First Submission Date that Met QC Criteria

Jul 2, 2024

First Posted Date

Jul 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

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).	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Radiologie II, CHU de Strasbourg	Recruiting	Strasbourg	Les Hôpitaux Universitaires de Strasbourg	67091	France

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D003711	Demyelinating Diseases

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D001327	Autoimmune Diseases

Browse Leaves

Not provided

Browse Branches

Not provided