Scan-Rescan Sub-Study of MS PATHS

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04123353

Enrollment

Registered

2019-10-10

Start date

2017-02-11

Completion date

2017-05-09

Last updated

2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Sensitivity and Specificity for Lesion Detection	Baseline up to Day 7
Overall Reproducibility of Brain Volume	Baseline up to Day 7
Overall Reproducibility of Lesions	Baseline up to Day 7
Intrascanner Reproducibility of Brain Volume	Baseline up to Day 7
Intrascanner Reproducibility of Lesions	Baseline up to Day 7
Interscanner Reproducibility of Brain Volume	Baseline up to Day 7
Interscanner 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
Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions	Baseline up to Day 7

Secondary

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

Countries

United States

Outcome results