MRI Exploration of Meningeal Inflammatory Disease | NCT04707170

Studies
MRI Exploration of Meningeal Inflammatory Disease

NCT04707170

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Dec 13, 2023Actual

Enrollment

302Actual

Phase

Not provided

Conditions

Interventions

MRI with gadolinium injection

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

Dec 2023

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

Jun 16, 2021Actual

Primary Completion Date

Jun 16, 2023Actual

Completion Date

Jun 16, 2023Actual

First Submitted Date

Jan 11, 2021

First Submission Date that Met QC Criteria

Jan 11, 2021

First Posted Date

Jan 13, 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

Dec 12, 2023

Last Update Posted Date

Dec 13, 2023Actual

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

Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which two additional sequences of 6 minutes duration will be added.

The MRI of routine care includes at least the following sequences:

3D T1 TFE 1.0 isotropic (2 minutes)
T2 TSE (2 minutes)
3D FLAIR pre-injection (opt) (3 minutes)
3D FLAIR post-injection (3 minutes)

As part of the research, the following sequences will be acquired:

FABIR pre-injection (3 minutes)
FABIR post-injection (3 minutes)

Patients hospitalized for a foreseeable duration of at least 24 hours will be offered participation in the longitudinal tab of the study, for which four non-injected MRI examinations will be performed. The examinations will be carried out remotely from the injected MRI (1h, 2h, 12h-15h, 24h-36h). These exams dedicated to research will include the following sequences for a maximum of 8 minutes:

3D T1 TFE 1.0 isotropic (2 minutes)
3D FLAIR (3 minutes)
FABIR (3 minutes)

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

302Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI with gadolinium injection	Device	Patients presenting for imaging for whom an MRI examination with gadolinium injection has been prescribed and who meet the inclusion and non-inclusion criteria will be offered to participate in the study. The patients included, hospitalized at the A. de Rothschild Foundation Hospital for at least 24 hours, may be included in the ancillary study to meet secondary objective number 5.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection of meningeal contrast enhancement with the flair sequence		1 DAY
detection of meningeal contrast enhancement with the FABIR sequence		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient over 18 years old
To benefit as part of his treatment of an MRI with injection of gadolinium
Express consent to participate in the study
Affiliate or beneficiary of a social security scheme

For the ancillary study to meet secondary endpoint number 5:

Patient over 18 years old
To benefit as part of his treatment of an MRI with injection of gadolinium
Hospitalized for an expected period of at least 48 hours after the time of inclusion
Express consent to participate in the study
Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

Patient benefiting from a legal protection measure
Pregnant or breastfeeding woman

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 for imaging for whom an MRI examination with gadolinium injection has been prescribed and who meet the inclusion and non-inclusion criteria will be offered to participate in the study.

The patients included, hospitalized at the A. de Rothschild Foundation Hospital for at least 24 hours, may be included in the ancillary study to meet secondary objective number 5

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
julien savatovsky	Hôpital fondation Adolphe de Rothschild	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hhopital fondation adolphe de rothschild		Paris		75019	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided