Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple Sclerosis (ENRAGED FLAIR)
Evaluation of a Combined MR Sequence for Simultaneous T2- and T1-Weighted Brain Imaging in Multiple Sclerosis
This study will evaluate a new brain MRI technique called ENRAGED FLAIR in patients with multiple sclerosis. MRI is central in the diagnosis and follow-up of multiple sclerosis because it can show inflammatory lesions in the brain. A standard MS brain MRI examination usually includes T2-FLAIR images, which are used to detect and assess MS lesions, and T1-weighted images, which provide anatomical information and help with interpretation of lesion location.
These image types are usually acquired as separate scans. ENRAGED FLAIR is designed to acquire both T2-FLAIR and T1-weighted images during the same MRI sequence. The purpose of this study is to compare ENRAGED FLAIR with standard clinical MRI in patients with multiple sclerosis.
Adult patients with multiple sclerosis who are already scheduled for a clinical brain MRI may be asked to participate. Participants will undergo one additional MRI sequence during the same visit. No extra contrast agent will be given, and no extra visit is required. The additional scan is expected to increase the examination time by about 5 to 10 minutes.
The study will assess whether ENRAGED FLAIR provides image quality and MS lesion visualization comparable to standard MRI. If successful, this technique may help shorten future MRI examinations for patients with multiple sclerosis while preserving clinically useful image information.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Multiple sclerosis (MS) is commonly monitored with brain MRI. T2-FLAIR imaging is central for detecting and following MS lesions, while T1-weighted imaging provides anatomical information that supports lesion localization and interpretation. In routine clinical MRI, these contrasts are usually acquired as separate sequences, which increases examination time.
ENRAGED FLAIR is a combined MRI acquisition designed to generate both 3D T2-FLAIR and T1-weighted brain images from a single sequence. The method uses otherwise unused recovery time in a FLAIR acquisition to acquire T1-weighted data. This may improve scan efficiency while preserving the clinically important information from both contrasts.
This study is a prospective intra-individual comparison in adult patients with MS undergoing clinically indicated brain MRI. Each participant will undergo standard clinical MRI sequences and one additional ENRAGED FLAIR acquisition during the same examination. No additional contrast agent or study visit is required.
Images from ENRAGED FLAIR will be compared with standard clinical T2-FLAIR and T1-weighted images. The evaluation will focus on MS lesion visualization, diagnostic image quality, and whether the simultaneously acquired T1-weighted images provide sufficient anatomical information for interpretation. Because each participant undergoes both standard MRI and ENRAGED FLAIR, each participant serves as their own control.
The study is intended to determine whether ENRAGED FLAIR can provide image quality comparable to standard MRI in MS while potentially enabling shorter future brain MRI protocols.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia
- Karolinska Universitetssjukhuset
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients, 18 years of age or older
- Diagnosis of multiple sclerosis
- Scheduled for a clinical brain MRI examination including T2-FLAIR and T1-weighted imaging
- Able to provide written informed consent
Exclusion Criteria:
- Age under 18 years
- Severe claustrophobia or inability to tolerate the additional MRI acquisition time
- Inability to provide written informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: ENRAGED FLAIR MRI
Participants undergo standard clinical brain MRI and one additional ENRAGED FLAIR MRI acquisition during the same examination.
ENRAGED FLAIR images will be compared with standard clinical T2-FLAIR and T1-weighted images acquired in the same participant.
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ENRAGED FLAIR is a combined MRI acquisition designed to generate both 3D T2-FLAIR and T1-weighted brain images from a single sequence.
The additional sequence is acquired during the same clinical MRI examination and does not involve extra contrast agent or an additional study visit.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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MRI Acquisition Time
Periodo de tiempo: From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.
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Acquisition time for ENRAGED FLAIR will be compared with the combined acquisition time of the corresponding standard clinical T2-FLAIR and T1-weighted MRI sequences in the same examination.
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From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale
Periodo de tiempo: At image review after the MRI examination, up to 12 months after enrollment
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Blinded neuroradiologists will compare ENRAGED FLAIR-derived T2-FLAIR images with standard clinical T2-FLAIR images for MS lesion assessment and routine clinical interpretation using a 5-point relative diagnostic image quality scale.
Scores range from 1 to 5: 1 = standard clinical T2-FLAIR strongly preferred, 2 = standard clinical T2-FLAIR slightly preferred, 3 = no preference/equivalent diagnostic quality, 4 = ENRAGED FLAIR-derived T2-FLAIR slightly preferred, and 5 = ENRAGED FLAIR-derived T2-FLAIR strongly preferred.
Higher scores favor ENRAGED FLAIR.
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At image review after the MRI examination, up to 12 months after enrollment
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T1-Weighted Relative Diagnostic Image Quality Score on a 5-Point Preference Scale
Periodo de tiempo: At image review after the MRI examination, up to 12 months after enrollment.
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Blinded neuroradiologists will compare ENRAGED FLAIR-derived T1-weighted images with standard clinical T1-weighted images for anatomical interpretability and support of MS lesion localization using a 5-point relative diagnostic image quality scale.
Scores range from 1 to 5: 1 = standard clinical T1-weighted image strongly preferred, 2 = standard clinical T1-weighted image slightly preferred, 3 = no preference/equivalent diagnostic quality, 4 = ENRAGED FLAIR-derived T1-weighted image slightly preferred, and 5 = ENRAGED FLAIR-derived T1-weighted image strongly preferred.
Higher scores favor ENRAGED FLAIR.
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At image review after the MRI examination, up to 12 months after enrollment.
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MS Lesion Volume Agreement
Periodo de tiempo: After image processing and analysis, up to 12 months after enrollment
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MS lesion volumes derived from ENRAGED FLAIR images will be compared with lesion volumes derived from standard clinical T2-FLAIR images using automated or semi-automated lesion segmentation.
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After image processing and analysis, up to 12 months after enrollment
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Automatic Brain Segmentation Agreement
Periodo de tiempo: After image processing and analysis, up to 12 months after enrollment
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Brain tissue segmentation results derived from ENRAGED FLAIR images will be compared with segmentation results derived from standard clinical MRI images using automated brain segmentation software.
Agreement will be assessed for relevant volumetric outputs used in MS image analysis.
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After image processing and analysis, up to 12 months after enrollment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Karl Henric Rydén, PhD, Karolinska University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K 2026-6150
- 2026-01765-01 (Otro identificador: Swedish Ethical Review Authority)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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