Reproducibility of Brain Volume and Lesion Measurements in Multiple Sclerosis: a Scan-Rescan Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions
Study Overview
Brief Summary
The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations.
- •Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive).
- •First MS symptom within the past 1 to 30 years.
Exclusion Criteria
- •Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit
- •Steroid treatment or suspected MS relapse within 6 weeks prior to Visit
- •Note: Other protocol specified inclusion and exclusion criteria may apply.
Outcomes
Primary Outcomes
Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions
Time Frame: Baseline up to Day 7
Intrascanner Reproducibility of Brain Volume
Time Frame: Baseline up to Day 7
Intrascanner Reproducibility of Lesions
Time Frame: Baseline up to Day 7
Interscanner Reproducibility of Brain Volume
Time Frame: Baseline up to Day 7
Sensitivity and Specificity for Lesion Detection
Time Frame: Baseline up to Day 7
Interscanner Reproducibility of Lesions
Time Frame: Baseline up to Day 7
Overall Reproducibility of Brain Volume
Time Frame: Baseline up to Day 7
Overall Reproducibility of Lesions
Time Frame: Baseline up to Day 7
Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions
Time Frame: Baseline up to Day 7
Secondary Outcomes
- Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners(Baseline up to Day 7)