Randomized, Blinded, Placebo-controlled Crossover Study Assessing Association Between Gadolinium-based Contrast Agent Administration and Transient Dyspnea/Arterial Phase Motion Artifact
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath
研究概览
简要总结
The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal renal function (serum eGFR >60)
排除标准
- •renal impairment
- •allergy to gadolinium-based contrast
- •metallic implanted devices
- •claustrophobia
- •pregnant and lactating females
研究组 & 干预措施
Eovist (gadoxetate disodium)
While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance.
干预措施: gadoxetate disodium (Drug)
Dotarem (gadoterate dimeglumine)
While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance.
干预措施: gadoterate dimeglumine (Drug)
Saline
While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance.
干预措施: Saline (Drug)
结局指标
主要结局
Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath
时间窗: following contrast administration, up to 5 minutes
Subject-reported Dyspnea, as Measured by Questionnaire Responses
时间窗: following contrast administration, up to 5 minutes
After each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold.
次要结局
- O2 Saturation Following Contrast Administration(following contrast administration, up to 5 minutes)
- Heart Rate Following Contrast Injection(following contrast administration, up to 5 minutes)
- Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale(following contrast administration, up to 5 minutes)
- Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging(following contrast administration, up to 5 minutes)