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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definity contrast agent | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definity contrast during ultrasound | Drug | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sapan N Ambani, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D006869 | Hydronephrosis |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D007674 | Kidney Diseases |
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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) |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |