Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Phase 1

Not yet recruiting

• Conditions: Vesico-Ureteral Reflux
• Interventions: Drug: Lumason

• Registration Number: NCT03653702
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Study Start: 2023-10-01
• Primary Completion: 2024-04
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast Enhanced Ultrasound	Lumason	Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason

Primary Outcome Measures

Name	Time	Method
Performance of CEUS result and comparison to DMSA	3 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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States