Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA vs. Ferumoxytol Vascular Enhanced MRI for Detection of Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in PAD Subjects Scheduled for DSA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels
研究概览
简要总结
The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI. Both methods will be compared with Digital Subtraction Angiography (DSA).
详细描述
This was a Phase 2, open-label, randomized, multicenter study to evaluate the efficacy and safety of a single administration of intravenous (IV) ferumoxytol at 3 dose levels as a VE-MRI imaging agent to facilitate detection of arterial stenosis in subjects with PAD. Eligible subjects were already scheduled for DSA to be completed within 14 days of the MR assessments. Nineteen sites randomized subjects in the study. The sites were selected such that an equal number of subjects could be scanned on the 3 major MRI 1.5 T platforms (Siemens, General Electric, and Philips).
Subjects were stratified by imaging platform and randomized to receive 1.0, 2.5, or 4.0 mg/kg IV ferumoxytol. On the same study day, subjects first underwent a noncontrast MRA, followed by administration of the randomized ferumoxytol dose and VE-MRI. Within 2 weeks subjects then underwent the previously scheduled DSA of the aortoiliac and superficial femoral arteries that served as the reference "gold standard."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Subjects with symptoms of PAD
- •Scheduled for DSA
排除标准
- •Critical leg ischemia manifested by ulcers, gangrene or leg amputation
- •Laboratory evidence of iron overload, liver disease, pregnancy
- •History of allergy to or recent exposure to radiocontrast, gadolinium chelates, or intravenous iron therapy
- •Clinical concerns about co-morbidities, subject suitability
研究组 & 干预措施
Cohort 1
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
干预措施: ferumoxytol (Drug)
Cohort 2
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
干预措施: ferumoxytol (Drug)
Cohort 3
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
干预措施: ferumoxytol (Drug)
结局指标
主要结局
To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels
时间窗: 3 weeks
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
时间窗: 3 weeks
Analysis of the sensitivity and specificity of VE-MRI by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms.
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
时间窗: 3 weeks
Analysis of the sensitivity and specificity of noncontrast MRA by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. The data were pooled across all imaging platforms.
次要结局
- To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.(3 weeks)
- Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels(3 weeks)
- Segment-level Positive and Negative Predictive Values of Noncontrast MRA(3 weeks)
- Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA(3 weeks)
- Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers(3 weeks)
- Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA(3 weeks)
- Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA(3 weeks)