Clinical trial NCT04123353: Scan-Rescan Sub-Study of MS PATHS
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be participants with MS enrolled in Study 888MS001 who have varying levels of disease severity and symptom duration.

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.


Eligibility criteria: Key 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.

Key Exclusion Criteria:

* Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit 1.
* Steroid treatment or suspected MS relapse within 6 weeks prior to Visit 1.

Note: Other protocol specified inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Overall Reproducibility of Brain Volume
timeFrame: Baseline up to Day 7
measure: Overall Reproducibility of Lesions
timeFrame: Baseline up to Day 7
measure: Intrascanner Reproducibility of Brain Volume
timeFrame: Baseline up to Day 7
measure: Intrascanner Reproducibility of Lesions
timeFrame: Baseline up to Day 7
measure: Interscanner Reproducibility of Brain Volume
timeFrame: Baseline up to Day 7
measure: Interscanner Reproducibility of Lesions
timeFrame: Baseline up to Day 7
measure: Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions
timeFrame: Baseline up to Day 7
measure: Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions
timeFrame: Baseline up to Day 7
measure: Sensitivity and Specificity for Lesion Detection
timeFrame: Baseline up to Day 7
Secondary outcomes:
measure: Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners
timeFrame: Baseline up to Day 7
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: New York
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: