Clinical trial NCT04819737: Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences
Official title: Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis (MS)
Keywords: spinal cord (SC) pathology
demyelinating lesions
Spinal cord MRI
Averaged magnetization inversion recovery acquisitions (AMIRA) sequence
Swiss MS Cohort (SMSC)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Freie Akademische Gesellschaft Basel
First posted: 2021-03-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants (embedded within the currently ongoing Swiss MS Cohort (SMSC) study) will undergo a single visit including a clinical interview, neurological examination and MRI.
Primary purpose: DIAGNOSTIC

Brief summary: This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Detailed description: An averaged magnetization inversion recovery acquisitions (AMIRA) sequence was proposed for SC MRI. This MR-sequence delivers excellent contrast between the SC gray and white matter as well as between the SC and cerebrospinal fluid (CSF) in clinically feasible-acquisition times. Moreover, the high quality and in-plane resolution of AMIRA images allows for segmentation of the SC gray and white matter with high accuracy and reproducibility. This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis according to established international criteria
* Steroid free period: \> 4 weeks
* Participation in the Swiss MS Cohort (SMSC) study

Exclusion Criteria:

* . History of severe (other) neurological, internal or psychiatric disease with SC affection
* MRI-related exclusion criteria (questionnaire):

  1. Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC)
  2. Pacemaker
  3. Claustrophobia
  4. Pregnancy, lactation
  5. Known hypersensitivity to gadolinium-based contrast media

Primary outcomes:
measure: Number of SC lesions
timeFrame: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
measure: Inter-observer agreement on SC lesion count
timeFrame: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
measure: Presence of ongoing inflammation (acute or chronic) in the SC
timeFrame: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Neurology
Study officials:
affiliation: University Hospital Basel, Department of Neurology
name: Katrin Parmar, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: