NCT04792866

Brief Summary

3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D FLAIR sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS). Recently, a study based on a small number of patients showed the interest of 3D FLAIR in the detection of the hypersignal of the optic nerve.The objective of this retrospective study is to determine whether a single 3D FLAIR sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

March 8, 2021

Last Update Submit

March 11, 2021

Conditions

Optic NeuritisMultiple SclerosisEncephalopathy

Outcome Measures

Primary Outcomes (1)

  • Detection of optic neuropathies using MRI

    MRI comparison of the diagnostic performance of the 3D FLAIR sequence and the T2 coronal in the detection of optic neuropathies.

    1 hour

Interventions

Magnetic Resonance ImagingDIAGNOSTIC_TEST

Comparing 3D FLAIR versus Coronal T2-WI MRI in detecting Optic Neuritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting with acute visual loss and explored by MRI

You may qualify if:

  • Age \> 18 years
  • Decrease in visual acuity explored in MRI between january 2018 and january 2020

You may not qualify if:

  • Past history of episode of Optic neuritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Optic NeuritisMultiple SclerosisBrain Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

January 1, 2018

Primary Completion

March 1, 2020

Study Completion

August 1, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

FR(1)