NCT04707144

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

January 11, 2021

Last Update Submit

December 12, 2023

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (7)

  • 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

    1 DAY

  • 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)

    1 day

  • 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)

    1 DAY

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

    1 DAY

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

    1 DAY

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

    1 DAY

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

    1 DAY

Interventions

MRI 1.5 teslaDEVICE

* 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)

Eligibility Criteria

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

The study will be offered prospectively to patients presenting to the imaging department for a 1.5T MRI for bone marrow exploration, in the context of inflammatory involvement of the nevrax

You may qualify if:

  • 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

You may not qualify if:

  • Patient benefiting from a legal protection measure
  • Pregnant, parturient or breastfeeding woman
  • Absolute or relative contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU DE Bordeaux

Bordeaux, 33000, France

Location

Chu de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Chu de Lille

Lille, 59000, France

Location

CHU de LYON

Lyon, 69002, France

Location

Hôpital privé des Peupliers

Paris, 75013, France

Location

Fondation Ophtalmologique Adolphe de Rothschild (FOR)

Paris, 75019, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

May 6, 2021

Primary Completion

June 6, 2023

Study Completion

June 28, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

FR(6)