Scan-Rescan Sub-Study of MS PATHS

Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123353
• Other study ID #: 888MS004
• Status: Completed
• Start date: February 11, 2017
• Est. completion date: May 9, 2017

Study information

• Verified date: October 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland
United States	Research Site	Cleveland	Ohio
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Reproducibility of Brain Volume		Baseline up to Day 7
Primary	Overall Reproducibility of Lesions		Baseline up to Day 7
Primary	Intrascanner Reproducibility of Brain Volume		Baseline up to Day 7
Primary	Intrascanner Reproducibility of Lesions		Baseline up to Day 7
Primary	Interscanner Reproducibility of Brain Volume		Baseline up to Day 7
Primary	Interscanner Reproducibility of Lesions		Baseline up to Day 7
Primary	Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions		Baseline up to Day 7
Primary	Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions		Baseline up to Day 7
Primary	Sensitivity and Specificity for Lesion Detection		Baseline up to Day 7
Secondary	Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners		Baseline up to Day 7