Phase 2 N=10 Diagnostic

Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Urinary Tract Infection · Vesicoureteral Reflux

Bottom Line

View on ClinicalTrials.gov: NCT02786810 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Visualization of Renal Scars Compared to Previous Imaging — 100 Percentage of previous scars visualized

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sulfur hexafluoride type-a lipid microspheres (Drug)
Age: Pediatric, Adult · 8+ yrs
Sex: All
Sponsor: University of Tennessee
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Visualization of Renal Scars Compared to Previous Imaging	100	—
SECONDARY Number of Participants With Adverse Events Related to the Study Drug.	1	—

Summary

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

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
Pregnancy and lactation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02786810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.