Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Vesico-Ureteral Reflux Clinical Trial

Official title:

Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03653702
• Other study ID #: P00027566
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: Nicholas Fisher
• Phone: 617-919-2643
• Email: Nicholas.Fisher[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vesico-Ureteral Reflux

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of CEUS result and comparison to DMSA	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	3 months after final participant completes participation