Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple Sclerosis

Официальное название

Evaluation of a Combined MR Sequence for Simultaneous T2- and T1-Weighted Brain Imaging in Multiple Sclerosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест ENRAGED FLAIR MRI
  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.

Первичные конечные точки

• MRI Acquisition Time [Срок оценки: From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.]

Вторичные конечные точки (4)

• T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale [Срок оценки: At image review after the MRI examination, up to 12 months after enrollment]
• T1-Weighted Relative Diagnostic Image Quality Score on a 5-Point Preference Scale [Срок оценки: At image review after the MRI examination, up to 12 months after enrollment.]
• MS Lesion Volume Agreement [Срок оценки: After image processing and analysis, up to 12 months after enrollment]
• Automatic Brain Segmentation Agreement [Срок оценки: After image processing and analysis, up to 12 months after enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Age under 18 years
• Severe claustrophobia or inability to tolerate the additional MRI acquisition time
• Inability to provide written informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07687693 · K 2026-6150 · 2026-01765-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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