Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
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|ClinicalTrials.gov Identifier: NCT02786810|
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : April 4, 2018
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection Vesicoureteral Reflux||Drug: Sulfur hexafluoride type-a lipid microspheres||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
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.
Drug: Sulfur hexafluoride type-a lipid microspheres
Used as a contrast to enhance renal ultrasound
Other Name: Lumason®
- Visualization of Renal Scars Compared to Previous Imaging [ Time Frame: 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.
- Number of Participants With Adverse Events Related to the Study Drug. [ Time Frame: 1 week ]The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786810
|United States, Tennessee|
|University of Tennessee Health Science Center|
|Memphis, Tennessee, United States, 38013|
|Principal Investigator:||David Hains, M.D.||University of Tennessee Health Science Center|