Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Phase 2

Completed

• Conditions: Urinary Tract Infection; Vesicoureteral Reflux
• Interventions: Drug: Sulfur hexafluoride type-a lipid microspheres

• Registration Number: NCT02786810
• Lead Sponsor: University of Tennessee

Brief Summary

The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-05
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-06-01
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-10-24
• Results First Submitted QC: 2018-03-05
• Results First Posted: 2018-04-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Informed consent
• Age more than or equal to 8 years
• Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux
• Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar
• Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast

Includes healthy volunteers

Exclusion Criteria

• Age less than 8years
• Allergy to contrast or related products
• Cardiac shunt/ congenital heart anomalies
• Abnormal baseline ECG
• Open heart surgery
• Evidence of retinopathy
• Patient in intensive care
• Unable to comply with study requirement
• History of emphysema
• Unable to maintain oxygen saturation of 92% on at room air
• Pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast	Sulfur hexafluoride type-a lipid microspheres	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.

Primary Outcome Measures

Name	Time	Method
Visualization of Renal Scars Compared to Previous Imaging	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events Related to the Study Drug.	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.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States