Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Conditions

• Vesico-Ureteral Reflux

Eligibility Criteria

Sex

ALL

Age

6 Months - 35 Years

Healthy Volunteers

Not accepted

Interventions

• Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] — DRUG
  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

Study Details

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.

Key Dates

First listed

Aug 31, 2018

Start date

Jul 1, 2027

Status verified

Dec 2025

Primary completion

Jun 30, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

70 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Contrast Enhanced Ultrasound
  Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason

Primary Outcome Measure

Performance of CEUS result and comparison to DMSA [ Time Frame: 3 months after final participant completes participation ]

Central Contacts

• Vera Rodic, MPH
  8572621693
  [email protected]
• Katherine Regis
  [email protected]

Locations (1)

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