Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03653702
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 57.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vesico-Ureteral Reflux	Drug: Lumason	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
• Actual Study Start Date: Aug 22, 2019
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contrast Enhanced Ultrasound Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason	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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Lee, Principal Investigator, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT03653702
• Other Study ID Numbers: P00027566
• First Posted: Aug 31, 2018
• Last Update Posted: Aug 4, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Vesico-Ureteral Reflux

Study Results

No Results Posted as of Aug 4, 2021