NCT03653702|Not Yet RecruitingPhase 1DMCFDA Drug
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Sponsor study identifier
interventional
70
1 country
1
Study Start
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2018
Actual (reported)August 31, 2018
Actual (reported)July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
3 months after final participant completes participation
Participants will undergo a contrast enhanced ultrasound (CEUS) using 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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Richard Lee
Boston Children's Hospital
First Submitted
August 28, 2018
First Posted
August 31, 2018
Study Start
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 2029
Prospective Pediatric Vesicoureteral Reflux Surgery Database
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 22, 2026
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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