DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Clinical Utility for Visualizing Pathology
研究概览
简要总结
Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis.
Participants: 100 participants with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI will be recruited.
Procedures (methods): Patients with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI who will have an additional non-FDA approved sequence (DANTE SPACE) added to their clinical scan. The investigational sequence requires less than 15 minutes and will be added following the standard MRI sequence.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 and older
- •Concern for intracranial vascular disease
- •Scheduled to undergo a clinical vessel wall MRI
排除标准
- •Claustrophobia
- •Implanted metallic devices, parts, vascular clips, or other foreign bodies.
- •Known hypersensitivity to gadolinium contrast or to any component of gadolinium contrast refractory to standard medications (antihistamines, steroids)
- •Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- •Any woman who is pregnant or has reason to believe she is pregnant via self report
结局指标
主要结局
Clinical Utility for Visualizing Pathology
时间窗: Baseline
The primary objective is to determine the percent of participants with a visible region of interest.
次要结局
未报告次要终点