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OpenTrials
Completed

NCT Number: NCT04707144

Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T

Inclusion visit (D0):

* verification of inclusion and non-inclusion criteria * information and collection of consent * standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence. * 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU DE Bordeaux, Bordeaux, France

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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 from a medullary exploration planned by MRI 1.5T as part of a first evaluation or a re-evaluation of inflammatory involvement of the nevrax
  • 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, parturient or breastfeeding woman
  • Absolute or relative contraindication to MRI

Treatment and study plan

MRI 1.5 tesla

Device
  • standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
  • 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes)

Primary outcomes

  1. Estimate the number of spinal cord injuries detected with the set of standard sequences (T1, T2 and STIR) that are not detected with the 3D PSIR sequence

    Time frame: 1 DAY

  2. Estimate the number of active lesions taking the contrast after injection of gadolinium, with the 3D PSIR sequence which is not detected in the set of standard sequences (T1, T2 and STIR)

    Time frame: 1 day

  3. Compare the diagnostic confidence expressed by the radiologist for the detection of spinal cord injuries with the 3D PSIR sequence compared to the set of standard sequences (T1, T2 and STIR)

    Time frame: 1 DAY

  4. Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)

    Time frame: 1 DAY

  5. Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)

    Time frame: 1 DAY

  6. Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence

    Time frame: 1 DAY

  7. Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence

    Time frame: 1 DAY

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

Acronym: ESPOIR1-5

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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