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Completed

NCT Number: NCT04707170

MRI Exploration of Meningeal Inflammatory Disease

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)

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Key information

Conditions

MRI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hhopital fondation adolphe de rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. detection of meningeal contrast enhancement with the flair sequence

    Time frame: 1 DAY

  2. detection of meningeal contrast enhancement with the FABIR sequence

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: EIME

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2021
Registry last updated
Dec 13, 2023

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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