Contrast Enhanced Ultrasound for Renal Obstruction
United States10 participantsStarted 2021-12-03
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to peak (TTP) ultrasound measurements
Timeframe: Immediately after contrast injected (approximately 30 minutes)
2
Peak intensity (PI) ultrasound measurements
Timeframe: Immediately after contrast injected (approximately 30 minutes)
3
Mean transit time (MTT) ultrasound measurements
Timeframe: Immediately after contrast injected (approximately 30 minutes)
4
Area under the curve (AUC) ultrasound measurements
Timeframe: Immediately after contrast injected (approximately 30 minutes)
5
Ratio of plateau and peak intensity ultrasound Measurements
Timeframe: Immediately after contrast injected (approximately 30 minutes)