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Completed

NCT Number: NCT04123353

Scan-Rescan Sub-Study of MS PATHS

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall Reproducibility of Brain Volume

    Time frame: Baseline up to Day 7

  2. Overall Reproducibility of Lesions

    Time frame: Baseline up to Day 7

  3. Intrascanner Reproducibility of Brain Volume

    Time frame: Baseline up to Day 7

  4. Intrascanner Reproducibility of Lesions

    Time frame: Baseline up to Day 7

  5. Interscanner Reproducibility of Brain Volume

    Time frame: Baseline up to Day 7

  6. Interscanner Reproducibility of Lesions

    Time frame: Baseline up to Day 7

  7. Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions

    Time frame: Baseline up to Day 7

  8. Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions

    Time frame: Baseline up to Day 7

  9. Sensitivity and Specificity for Lesion Detection

    Time frame: Baseline up to Day 7

Secondary outcomes

  1. Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners

    Time frame: Baseline up to Day 7

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2019
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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