Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Imaging Quality Score
研究概览
简要总结
The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male or female subjects between 18-45 years of age
排除标准
- •Pregnant and lactating females
- •known renal impairment
- •allergy to gadolinium-based contrast
- •metallic implanted devices
- •claustrophobia.
研究组 & 干预措施
0.03 mmol/kg
FDA-approved dose for lower extremity arterial imaging
干预措施: gadofosveset (Drug)
0.02 mmol/kg
干预措施: gadofosveset (Drug)
0.01 mmol/kg
干预措施: gadofosveset (Drug)
结局指标
主要结局
Imaging Quality Score
时间窗: 14 weeks
Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows: 1. poor / nondiagnostic 2. adequate 3. good 4. excellent
次要结局
- Quantitative Analysis Noise Ratios(14 weeks)