Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

This study is testing a radiation-free technique called contrast-enhanced ultrasound to evaluate kidney scarring, which is often caused by vesico-ureteral reflux (VUR). This technique uses a contrast agent called Lumason (Sulfur Hexafluoride Lipid Type A Microspheres) injected into a vein to help doctors see kidney structures more clearly. The goal is to see if this method can replace DMSA scans, which involve radiation exposure. You might be able to join if you are between 6 months and 35 years old, have VUR, and are scheduled for a DMSA scan at Boston Children's Hospital. The study will be considered successful if the contrast-enhanced ultrasound results compare well to DMSA scans. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 70 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint will be measured at 3 months after the final participant completes participation.

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NCT03653702

Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Not Yet Recruiting
PHASE1Ages 6–35InterventionalDiagnostic
Boston Children's Hospital
~70 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance of CEUS result and comparison to DMSA
Measured over 3 months after final participant completes participation
Vesico-Ureteral Reflux
1 sites across 1 states
Massachusetts1
  • Richard Lee · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Eligibility criteria

Inclusion

patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and/or renal scarring

Exclusion

patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.
  • Performance of CEUS result and comparison to DMSA3 months after final participant completes participation

    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