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Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Boston Children's Hospital logo

Boston Children's Hospital

Status and phase

Not yet enrolling
Phase 1

Conditions

Vesico-Ureteral Reflux

Treatments

Drug: Lumason

Study type

Interventional

Funder types

Other

Identifiers

NCT03653702
P00027566

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

6 months to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Contrast Enhanced Ultrasound
Experimental group
Description:
Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason
Treatment:
Drug: Lumason

Trial contacts and locations

1

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Central trial contact

Amy Chan; Nicholas Fisher

Data sourced from clinicaltrials.gov

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