Urinary Tract InfectionPhase 2NCT02786810
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
A Phase 2 study testing Sulfur hexafluoride type-a lipid microspheres in people with Urinary Tract Infection and Vesicoureteral Reflux, run by University of Tennessee at 1 site in United States.
Trial summary
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound. Read more about this study
- Who is it for?
- Ages 8 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection, Vesicoureteral Reflux
- What is being tested?
- Sulfur hexafluoride type-a lipid microspheres
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Informed consent
- Age more than or equal to 8 years
- Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux
- Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar
- Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast
- Includes healthy volunteers
Who cannot join
- Age less than 8years
- Allergy to contrast or related products
- Cardiac shunt/ congenital heart anomalies
- Abnormal baseline ECG
- Open heart surgery
- Evidence of retinopathy
Show all 11Show fewer
- Patient in intensive care
- Unable to comply with study requirement
- History of emphysema
- Unable to maintain oxygen saturation of 92% on at room air
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38013
About this study
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
- Conditions
- Urinary Tract Infection, Vesicoureteral Reflux
- Being tested
- Sulfur hexafluoride type-a lipid microspheres
- Medical subject headings
- Urinary Tract Infections, Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur hexafluoride type-a lipid microspheresDrug
Also called Lumason®
Used as a contrast to enhance renal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Contrast | Other | All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Receives: Drug: Sulfur hexafluoride type-a lipid microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of Renal Scars Compared to Previous Imaging
The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent.
Measured: 1 hour
Secondary outcomes (1)
Number of Participants With Adverse Events Related to the Study Drug.
The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hains, M.D., Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786810
- Sponsor's protocol ID
- 1504311FB
- Status last verified
- May 2016
- First submitted
- 17 May 2016
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
- ClinicalTrials.gov ID
- NCT02786810
- Acronym / sponsor ID
- 1504311FB
- Conditions
- Urinary Tract Infection, Vesicoureteral Reflux
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 4 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast | Other | Drug: Sulfur hexafluoride type-a lipid microspheresAll subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Informed consent
- Age more than or equal to 8 years
- Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux
- Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar
- Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast
Key exclusion criteria (11 listed)
- Age less than 8years
- Allergy to contrast or related products
- Cardiac shunt/ congenital heart anomalies
- Abnormal baseline ECG
- Open heart surgery
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 type-a lipid microspheresAlso: Lumason®Used as a contrast to enhance renal ultrasound | Drug | Contrast |
Primary outcome
Visualization of Renal Scars Compared to Previous Imaging
Time frame: 1 hour
The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent.
1 secondary outcome
Number of Participants With Adverse Events Related to the Study Drug.
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
David Hains, M.D. principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfur hexafluoride type-a lipid microspheres in people with Urinary Tract Infection and Vesicoureteral Reflux, run by University of Tennessee 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 11 May 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of Renal Scars Compared to Previous Imaging (time frame: 1 hour). 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 11 May 2018.