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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after final participant completes participation
Awards & highlights

Study Summary

This trial is studying a safe, radiation-free ultrasound technique that may improve the ability to diagnose or evaluate kidney scarring.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Performance of CEUS result and comparison to DMSA

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

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
756 Previous Clinical Trials
5,579,094 Total Patients Enrolled

Media Library

Lumason Clinical Trial Eligibility Overview. Trial Name: NCT03653702 — Phase 1
Vesicoureteral Reflux Research Study Groups: Contrast Enhanced Ultrasound
Vesicoureteral Reflux Clinical Trial 2023: Lumason Highlights & Side Effects. Trial Name: NCT03653702 — Phase 1
Lumason 2023 Treatment Timeline for Medical Study. Trial Name: NCT03653702 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participants in this trial over 60?

"Participants must be between 6 months and 35 years of age in order to join this medical study."

Answered by AI

Are there any vacancies available in the trial for prospective participants?

"Unfortunately, this clinical trial has concluded its recruitment phase. It was initially posted on August 22nd 2019 and underwent its last update on the 3rd of August 2021. Alternatively, there are currently three trials enrolling patients with vesico-ureteral reflux and 14 studies leveraging Lumason looking for participants to join in their research initiatives."

Answered by AI

What is the current number of individuals taking part in this research study?

"Unfortunately, this clinical trial is not accepting recruits at the moment. It was first posted on August 22nd 2019 and its most recent update occurred on August 3rd 2021. If you are interested in other trials, there are currently 3 studies involving vesico-ureteral reflux that require volunteers along with 14 research initiatives related to Lumason treatments."

Answered by AI

What potential risks should one be aware of when considering Lumason?

"The safety of Lumason was appraised as a 1, indicating that it is in its early stages and only has limited data to support its efficacy."

Answered by AI

Is this experiment a pioneering endeavor?

"Lumason has been under investigation since 2017, when the first trial was conducted by Bracco Diagnostics Inc. After a successful Phase < 1 approval in 2018, there are now 14 active studies running across 10 metropolises and 3 nations."

Answered by AI

Are there any other empirical investigations involving Lumason?

"Currently, 14 different clinical trials are in progress for Lumason. Of those experiments, two are at Phase 3 and 18 research sites can be found throughout Philadelphia, Pennsylvania."

Answered by AI

Is there an opportunity to take part in this experiment?

"This medical trial is currently seeking 70 patients with vesico-ureteral reflux aged between 6 months and 35 years. To be eligible, the participant must meet certain requirements: they must have been scheduled for a Boston Children's Hospital (BCH) DMSA scan to assess renal function or scarring and also fit within the age range of 6 month olds up to 35 year olds."

Answered by AI
~0 spots leftby Apr 2024