Vesico-Ureteral RefluxPhase 1NCT03653702
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
A Phase 1 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] in people with Vesico-Ureteral Reflux, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 35 years
- Conditions the study is for
- Vesico-Ureteral Reflux
- What is being tested?
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine Regis contact
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
Amy Chan, B.A., 347-854-6840, amy.chan@childrens.harvard.edu
Emily Morrison, B.S., 617-919-2637, emily.morrison@childrens.harvard.edu
About this study
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
- Being tested
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Medical subject headings
- Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]Drug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Contrast Enhanced Ultrasound | Experimental | Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason Receives: Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after final participant completes participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jul 2027 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesico-Ureteral RefluxStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Lee, Boston Children's Hospital
- Investigators
- Richard Lee, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653702
- Sponsor's protocol ID
- P00027566
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2018
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
- ClinicalTrials.gov ID
- NCT03653702
- Acronym / sponsor ID
- P00027566
- Conditions
- Vesico-Ureteral Reflux
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast Enhanced Ultrasound | Experimental | Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason |
Who may qualify
- Ages
- 6 months to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]Also: LumasonLumason 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 | Drug | Contrast Enhanced Ultrasound |
Primary outcome
Performance of CEUS result and comparison to DMSA
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Related trials for Vesico-Ureteral Reflux
RecruitingPhase 3
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter
Not yet recruiting
Diagnostic Performance of PIC Cystogram vs VCUG in Children
Pediatric Urology
Recruiting
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
VUR - Vesicoureteric Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Regis contact
Richard Lee principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] in people with Vesico-Ureteral Reflux, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera Rodic, MPH (8572621693, vera.rodic@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of CEUS result and comparison to DMSA (time frame: 3 months after final participant completes participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.