Contrast Enhanced Ultrasound for Renal Obstruction
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
- Time to peak (TTP) ultrasound measurements
研究概览
简要总结
This research is studying Definity ultrasound contrast agent, which is already approved by the Food and Drug Administration (FDA) for the ultrasound evaluation of the liver and heart. This research will investigate the ability to use ultrasound imaging with ultrasound contrast agents to evaluate kidney obstruction.
Eligible participants that are enrolled will have two visits (one before and one after the planned surgery to relieve the kidney obstruction).
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
- •Unilateral renal obstruction confirmed by Nuclear Medicine MAG3 Dynamic Renal Scan (diuretic t (time) ½ >20 minutes)
- •Obstructed kidney with differential function >15% confirmed by Nuclear Medicine Mercaptoacetyltriglycine (MAG3) Dynamic Renal Scan within less or equal (<=) 6 months from enrollment
- •Patient has elected to move forward with pyeloplasty or proximal ureteroureterostomy to correct the obstruction
排除标准
- •Solitary kidney
- •Any abnormalities of contralateral collecting system (for example (e.g.) hydronephrosis, renal calculi, duplicated collecting system)
- •Known vesicoureteral reflux
- •Ureteral stent in place in the obstructive kidney
- •Patients without a Nuclear Medicine MAG3 Dynamic Renal Scan
- •Previous history of hypersensitivity to Ultrasound Contrast Agents or Definity (perflutren lipid microspheres))
- •Previous sensitivity to polyethylene glycol
- •Pregnant or breastfeeding females
- •Body mass index (BMI) >=40 without prior ultrasound confirming ability to adequately visualize the kidneys (Elevated BMI is known to decrease ability to image the kidneys)
- •Global renal function with a Glomerular Filtration Rate (GFR) <30 (chronic kidney disease Stage 4 & 5 excluded)
- •Unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, presence of a cardiac shunt)
研究组 & 干预措施
Definity contrast agent
干预措施: Definity contrast during ultrasound (Drug)
结局指标
主要结局
Time to peak (TTP) ultrasound measurements
时间窗: Immediately after contrast injected (approximately 30 minutes)
Differences in ultrasound contrast measurements between obstructed and normal kidneys
Peak intensity (PI) ultrasound measurements
时间窗: Immediately after contrast injected (approximately 30 minutes)
Differences in ultrasound contrast measurements between obstructed and normal kidneys
Mean transit time (MTT) ultrasound measurements
时间窗: Immediately after contrast injected (approximately 30 minutes)
Differences in ultrasound contrast measurements between obstructed and normal kidneys
Ratio of plateau and peak intensity ultrasound Measurements
时间窗: Immediately after contrast injected (approximately 30 minutes)
Differences in ultrasound contrast measurements between obstructed and normal kidneys
Area under the curve (AUC) ultrasound measurements
时间窗: Immediately after contrast injected (approximately 30 minutes)
Differences in ultrasound contrast measurements between obstructed and normal kidneys
次要结局
- Fall time (FT) ultrasound measurements(Immediately after contrast injected (approximately 30 minutes))
- Enhanced slope ultrasound measurements(Immediately after contrast injected (approximately 30 minutes))
- Initial intrarenal microcirculatory transmit time ultrasound measurements(Immediately after contrast injected (approximately 30 minutes))
- Contrast arrival time (AT) ultrasound measurements(Immediately after contrast injected (approximately 30 minutes))
- Time from peak to baseline (TPB) ultrasound measurements(Immediately after contrast injected (approximately 30 minutes))
- Final plateau intensity ultrasound measurements(Immediately after contrast injected (approximately 30 minutes))
研究者
Sapan Ambani
Associate Professor of Urology
University of Michigan