Scan-Rescan Sub-Study of MS PATHS

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04123353
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-11
• Primary Completion: 2017-05-09
• Study Completion: 2017-05-09
• Study First Submitted: 2019-09-24
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrascanner Reproducibility of Brain Volume	Baseline up to Day 7
Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions	Baseline up to Day 7
Intrascanner Reproducibility of Lesions	Baseline up to Day 7
Interscanner Reproducibility of Brain Volume	Baseline up to Day 7
Sensitivity and Specificity for Lesion Detection	Baseline up to Day 7
Interscanner Reproducibility of Lesions	Baseline up to Day 7
Overall Reproducibility of Brain Volume	Baseline up to Day 7
Overall Reproducibility of Lesions	Baseline up to Day 7
Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions	Baseline up to Day 7

Secondary Outcome Measures

Name	Time	Method
Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners	Baseline up to Day 7

Trial Locations

Locations (1)

Research Site; 🇺🇸 Cleveland, Ohio, United States