3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neur... | NCT04792866

Studies
3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis (FLACON)

NCT04792866

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Mar 15, 2021Actual

Enrollment

1,200Actual

Phase

Not provided

Conditions

Optic Neuritis
Multiple Sclerosis
Encephalopathy

Interventions

Magnetic Resonance Imaging

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Aug 1, 2020Actual

First Submitted Date

Mar 8, 2021

First Submission Date that Met QC Criteria

Mar 8, 2021

First Posted Date

Mar 11, 2021Actual

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

Mar 11, 2021

Last Update Posted Date

Mar 15, 2021Actual

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

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.

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

1,200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging	Diagnostic Test	Comparing 3D FLAIR versus Coronal T2-WI MRI in detecting Optic Neuritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Past history of episode of Optic neuritis

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

Patients presenting with acute visual loss and explored by MRI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Fondation Adolphe de Rothschild		Paris	Île-de-France Region	75019	France

Condition Browse Module

MeSH Terms

ID	Term
D009902	Optic Neuritis
D009103	Multiple Sclerosis
D001927	Brain Diseases

Ancestor Terms

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided