Back to resultsContrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Primary Purpose
Urinary Tract Infection, Vesicoureteral Reflux
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sulfur hexafluoride type-a lipid microspheres
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age less than 8years
- Allergy to contrast or related products
- Cardiac shunt/ congenital heart anomalies
- Abnormal baseline ECG
- Open heart surgery
- Evidence of retinopathy
- 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
Sites / Locations
- University of Tennessee Health Science Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Contrast
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02786810
Brief Title
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Official Title
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Vesicoureteral Reflux
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sulfur hexafluoride type-a lipid microspheres
Other Intervention Name(s)
Lumason®
Intervention Description
Used as a contrast to enhance renal ultrasound
Primary Outcome Measure Information:
Title
Visualization of Renal Scars Compared to Previous Imaging
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events Related to the Study Drug.
Description
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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Age less than 8years
Allergy to contrast or related products
Cardiac shunt/ congenital heart anomalies
Abnormal baseline ECG
Open heart surgery
Evidence of retinopathy
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hains, M.D.
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38013
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
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