Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

University of Tennessee

Status and phase: Completed; Phase 2

Conditions: Urinary Tract Infection; Vesicoureteral Reflux

Treatments: Drug: Sulfur hexafluoride type-a lipid microspheres

Study type: Interventional

Funder types: Other

Identifiers

NCT02786810

1504311FB

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 8 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Contrast

Other group

Description:

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.

Treatment:

Drug: Sulfur hexafluoride type-a lipid microspheres