Contrast Enhanced Ultrasound for Renal Obstruction

Study Overview
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Brief Summary
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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).

Official Title
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Contrast Enhanced Ultrasound for Renal Obstruction

Conditions
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Kidney; Obstruction, Renal Obstruction

Intervention / Treatment
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* Drug: Definity contrast during ultrasound


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Definity contrast agent<br> | Drug: Definity contrast during ultrasound<br>* Participants will undergo an ultrasound contrast evaluation of both kidneys. This will include placement of an intravenous (IV) catheter in a vein and the delivery of Definity ultrasound contrast agent through the IV. Imaging will be completed for each kidney. The proposed total dose for adult patients will not exceed 20 microliters/kilograms (kg). Each individual dose not to exceed 10 microliters/kg. At initiation of patient studies, the dose will start at 10 microliters/kg for the first injection and a second 10 microliters/kg dose to evaluate the contralateral kidney. However, if ultrasound findings in patient studies demonstrate a dose that is too high (unable to make accurate ultrasound assessment), the dose will be reduced.<br>* Other names: Perflutren Lipid Microsphere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to peak (TTP) ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Peak intensity (PI) ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Mean transit time (MTT) ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Area under the curve (AUC) ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Ratio of plateau and peak intensity ultrasound Measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast arrival time (AT) ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Enhanced slope ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Fall time (FT) ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Time from peak to baseline (TPB) ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Final plateau intensity ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 
| Initial intrarenal microcirculatory transmit time ultrasound measurements | Differences in ultrasound contrast measurements between obstructed and normal kidneys | Immediately after contrast injected (approximately 30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound imaging, ultrasound contrast agents, kidney tissue, hydronephrosis