NCT02786810已完成2 期
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Visualization of Renal Scars Compared to Previous Imaging
研究概览
简要总结
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
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
- 8 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Age more than or equal to 8 years
- •Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux
- •Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar
- •Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast
- •Includes healthy volunteers
排除标准
- •Age less than 8years
- •Allergy to contrast or related products
- •Cardiac shunt/ congenital heart anomalies
- •Abnormal baseline ECG
- •Open heart surgery
- •Evidence of retinopathy
- •Patient in intensive care
- •Unable to comply with study requirement
- •History of emphysema
- •Unable to maintain oxygen saturation of 92% on at room air
- •Pregnancy and lactation
研究组 & 干预措施
Contrast
Other
All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.
干预措施: Sulfur hexafluoride type-a lipid microspheres (Drug)
结局指标
主要结局
Visualization of Renal Scars Compared to Previous Imaging
时间窗: 1 hour
The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent.
次要结局
- Number of Participants With Adverse Events Related to the Study Drug.(1 week)
研究者
研究点 (1)
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