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)

Patrocinadores

Patrocinador principal: Biogen

Fuente Biogen
Resumen breve

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.

Estado general Completed
Fecha de inicio February 11, 2017
Fecha de Terminación May 9, 2017
Fecha de finalización primaria May 9, 2017
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
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
Sensitivity and Specificity for Lesion Detection Baseline up to Day 7
Resultado secundario
Medida Periodo de tiempo
Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners Baseline up to Day 7
Inscripción 30
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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.

Género: All

Edad mínima: 21 Years

Edad máxima: 55 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Medical Director Study Director Biogen
Ubicación
Instalaciones:
Research Site | Baltimore, Maryland, 21205, United States
Research Site | New York, New York, 10016, United States
Research Site | Cleveland, Ohio, 44195, United States
Ubicacion Paises

United States

Fecha de verificación

October 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Retrospective

Fuente: ClinicalTrials.gov