What side effects are associated with this type of intervention?

Common treatments for Vesicoureteral Reflux (VUR) include antibiotic prophylaxis, endoscopic injection, and surgical reimplantation. Antibiotic prophylaxis can lead to side effects such as gastrointestinal disturbances and antibiotic resistance. Endoscopic injection, which involves injecting a bulking agent to prevent reflux, may cause temporary hematuria, urinary tract infections, and, rarely, ureteral obstruction. Surgical reimplantation, a more invasive option, carries risks such as bleeding, infection, and anesthesia-related complications. Contrast-enhanced ultrasound with Lumason, used for imaging, is generally well-tolerated but may cause mild side effects like injection site reactions and, rarely, allergic reactions.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Vesicoureteral Reflux that directly match the diagnostic imaging technique of contrast-enhanced ultrasound with Lumason. However, traditional treatments for VUR include prophylactic antibiotics to prevent urinary tract infections and surgical interventions such as ureteral reimplantation. Diagnostic imaging techniques like contrast-enhanced ultrasound with Lumason are being studied to improve the evaluation of renal structures without the risks associated with radiation exposure.

What other types of research exist?

Promising novel alternatives to Contrast-Enhanced Ultrasound with Lumason for Vesicoureteral Reflux patients include advanced MRI techniques such as functional MRI (fMRI) and diffusion-weighted imaging (DWI). These methods offer detailed imaging of renal structures without radiation exposure and can provide valuable information on renal function and anatomy.

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Lumason for Vesicoureteral Reflux

Phase 1

Waitlist Available

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 65 years old

Must not have

Patients with severe cardio-pulmonary diseases will also be excluded.

Patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after final participant completes participation

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new, safer ultrasound technique that uses a special dye called Lumason to get clearer images of the kidneys. It aims to help diagnose kidney scarring without the need for more expensive and risky tests that involve radiation. The dye helps highlight kidney structures, making it easier for doctors to see any damage.

Who is the study for?

The RAFTERS trial is for individuals aged 6 months to 35 years who need a DMSA scan at Boston Children's Hospital to check kidney function or scarring. It's not for those with severe heart/lung diseases or major congenital kidney abnormalities like horseshoe kidney, malrotation, or multicystic dysplastic kidney.

What is being tested?

This study tests a radiation-free technique called contrast-enhanced ultrasound using Lumason dye to diagnose renal scarring. It aims to see if this method can replace the traditional DMSA scan, which involves more cost, radiation exposure and potential sedation.

What are the potential side effects?

Lumason injection may cause side effects such as allergic reactions. However, it is considered safer than traditional contrast agents used in DMSA scans that also carry risks of allergy and require radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 months and 35 years old and scheduled for a renal function scan at BCH.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe heart or lung diseases.

Select...

I have a major birth defect in my kidney's structure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after final participant completes participation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after final participant completes participation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after final participant completes participation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance of CEUS result and comparison to DMSA

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast Enhanced UltrasoundExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium 1,2-Dipalmitoyl-sn-glycero-3-phospho-(1'-rac-glycerol)

FDA approved

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Vesicoureteral Reflux (VUR) include antibiotic prophylaxis, surgical intervention, and endoscopic injection. Antibiotic prophylaxis works by preventing urinary tract infections (UTIs) that can exacerbate VUR and lead to kidney damage. Surgical intervention, such as ureteral reimplantation, corrects the anatomical defect causing reflux, thereby preventing urine from flowing backward into the kidneys. Endoscopic injection involves injecting a bulking agent to create a valve mechanism that prevents reflux. These treatments are crucial for VUR patients as they aim to prevent recurrent UTIs and protect kidney function. Contrast-Enhanced Ultrasound with Lumason is relevant as it offers a radiation-free method to monitor the effectiveness of these treatments and detect any complications, thereby improving patient safety and treatment outcomes.