Evaluation of a Combined MR Sequence for Simultaneous T2- and T1-Weighted Brain Imaging in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- MRI Acquisition Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Outcome assessors performing image review will be masked to the acquisition method when feasible. Images will be reviewed in randomized order. Participants and MRI staff will not be masked because the ENRAGED FLAIR acquisition is added to the clinical MRI examination.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Age under 18 years
- •Severe claustrophobia or inability to tolerate the additional MRI acquisition time
- •Inability to provide written informed consent
研究组 & 干预措施
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.
干预措施: ENRAGED FLAIR MRI (Diagnostic Test)
结局指标
主要结局
MRI Acquisition Time
时间窗: From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.
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.
次要结局
- T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale(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(At image review after the MRI examination, up to 12 months after enrollment.)
- MS Lesion Volume Agreement(After image processing and analysis, up to 12 months after enrollment)
- Automatic Brain Segmentation Agreement(After image processing and analysis, up to 12 months after enrollment)
研究者
Henric Ryden
Principal Investigator
Region Stockholm