NCT02896647

Brief Summary

This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 14, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

September 7, 2016

Last Update Submit

September 10, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • number of spinal cord lesions

    baseline

Eligibility Criteria

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

patients scheduled for spinal cord MRI exploration for the assessment of a neuraxis inflammatory disease

You may qualify if:

  • age ≥ 18 years old
  • patients scheduled for spinal cord MRI exploration for the assessment of neuraxis inflammatory diseases

You may not qualify if:

  • contraindication to MRI
  • allergy to contrast media
  • patient under legal protection
  • no health insurance coverage
  • patient's refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A De Rothschild

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 Officials

  • Augustin LECLER, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

December 14, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations

FR(1)