Scan-Rescan Sub-Study of MS PATHS

October 9, 2019 updated by: Biogen

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)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2017

Primary Completion (Actual)

May 9, 2017

Study Completion (Actual)

May 9, 2017

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 888MS004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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