Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

University of Tennessee1 site in 1 country10 target enrollmentMarch 2016

ConditionsUrinary Tract Infection Vesicoureteral Reflux

InterventionsSulfur hexafluoride type-a lipid microspheres

DrugsSulfur hexafluoride type-a lipid microspheres

Overview

Phase: Phase 2
Intervention: Sulfur hexafluoride type-a lipid microspheres
Conditions: Urinary Tract Infection
Sponsor: University of Tennessee
Enrollment: 10
Locations: 1
Primary Endpoint: Visualization of Renal Scars Compared to Previous Imaging
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

November 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Tennessee

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Contrast

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.

Intervention: Sulfur hexafluoride type-a lipid microspheres

Outcomes

Primary Outcomes

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.