Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

NCT03653702 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: P00027566
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesico-Ureteral Reflux

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Contrast Enhanced Ultrasound

EXPERIMENTAL

Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason

Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

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

Also known as: Lumason

Contrast Enhanced Ultrasound

Eligibility Criteria

• Age: 6 Months - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Richard Lee

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Rodic, MPH

CONTACT

8572621693; vera.rodic@childrens.harvard.edu

Katherine Regis

CONTACT

Katherine.Regis@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2025-12

Locations

US (1)