Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

Detection of Spinal Cord Lesions Using the MP2RAGE Sequence in Inflammatory Diseases of the Neuraxis

NCT06589999 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-07-31
Last updated
2026-01-05

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

MP2RAGE sequence

MP2RAGE sequence: Addition of MRI sequence MP2RAGE

Study summary

Since the last revision of the MRI guidelines in multiple sclerosis (MS, MAGNIMS) and the McDonald criteria in 2017, all spinal cord lesions must be counted to increase the sensitivity and specificity of the diagnosis of MS. Focal lesions of the spinal cord are more frequently located in the cervical segments than in the lower segments of the spinal cord and occupy the lateral and posterior columns, although the central grey matter may not be spared. Cervical involvement is difficult to study because of the small size of the lesions and the loss of signal in the cervical region. As a result, the detection of cervical lesions on MRI is sub-optimal.

In this context, standardised acquisition protocols have been proposed.

For MRI of the spinal cord, at least two of the following sagittal sequences are recommended: T2, STIR, double inversion recovery, T1 with gadolinium injection, and/or T2 axial acquisitions.

Recently, our team validated the superiority of 3D PSIR and 3D FGAPSIR sequences, which offer better detection performance than T2 and STIR on 3 Tesla MRI.

Other studies have also shown the contribution of the MP2RAGE sequence to the detection of spinal cord lesions in MS, compared with the set of sequences classically recommended. The MP2RAGE sequence is a T1 sequence, which creates a composite image, limiting field inhomogeneity bias while providing a quantitative T1 map. It has recently been optimised for the spinal cord, and has been only minimally evaluated in the context of MS.

The aim of this study is to evaluate the effectiveness of the MP2RAGE sequence in comparison with the set of conventional sequences recommended for the detection of spinal cord lesions in MS patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged over 18 years * scheduled to undergo 1.5T or 3T MRI of the spinal cord as part of an initial assessment or reassessment of inflammatory neuraxial disease. * Express consent to participate in the study * Member or beneficiary of a social security scheme Exclusion Criteria: * Patient benefiting from a legal protection measure * Pregnant women * Absolute or relative contraindication to 1.5T or 3T MRI

Primary outcome measure(s)

  • In patients with inflammatory neuraxial disease, estimate the number of cervical lesions detected with the MP2RAGE sequence that were not detected with the recommended standard set. — Day 0
    The images will be reviewed by two radiologists who will be blinded to each other and who will each estimate the number of lesions detected on the images obtained with each of the sequences. Images from the same patient (standard set and MP2RAGE) will not be read at the same time. Readers will be instructed not to validate a lesion that is too difficult to see, but only those that are true lesions a priori. In the event of disagreement between the two radiologists, a consensus will be sought with a third reader.

Trial sites (1)

FacilityCityRegionStatus
Hopital Fondation Adolphe de Rothschild Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06589999 on ClinicalTrials.gov ↗ ← All trials in France