Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Phase 2CompletedNCT02786810

University of Tennessee10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Urinary Tract Infection Vesicoureteral Reflux

Interventions

Sulfur hexafluoride type-a lipid microspheresDRUG

Used as a contrast to enhance renal ultrasound

Eligibility

Sex: ALLMin age: 8 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Visualization of Renal Scars Compared to Previous Imaging

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.

Time frame: 1 hour

Secondary Outcomes

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

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.

Time frame: 1 week

Data from ClinicalTrials.gov

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