NCT03653702

Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vesico-Ureteral Reflux

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-01
• Completion: 2024-06-01
• First posted: 2018-08-31
• Last updated: 2023-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study