A Phase 1 interventional study of Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] in Vesico-Ureteral Reflux, sponsored by Boston Children's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 6 Months to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Boston Children's Hospital · Phase 1, Interventional, and Diagnostic
In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and/or injection of contrast agents with the potential to cause allergic reactions.
28 studies on the registry are indexed under Vesico-Ureteral Reflux; 4 are open to participants now.
This study's planned enrollment of 70 is above the median of 62 across 20 interventional studies indexed under Vesico-Ureteral Reflux.
Browse Vesico-Ureteral Reflux studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason
Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
Lumason will be used as the contrast agent. Standard Lumason dose will be used: 0.03mL/kg up to a maximum dose of 2.4 milliliter (mL) per injection
Also known as: Lumason
Performance of CEUS result and comparison to DMSA
DMSA will be used as gold standard to evaluate CEUS test performance. Sensitivity and specificity of CEUS renal scarring detection will be calculated accordingly. Bivariate and multivariate analyses will be completed to compare patient characteristics between those with good and poor CEUS performance to investigate if CEUS performs better in patients with specific covariates
Time frame: 3 months after final participant completes participation
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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