Phase 2
Completed N=10
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Source: ClinicalTrials.gov NCT02786810 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Visualization of Renal Scars Compared to Previous Imaging — 100 Percentage of previous scars visualized
Summary
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visualization of Renal Scars Compared to Previous Imaging |
100 | — |
| SECONDARY Number of Participants With Adverse Events Related to the Study Drug. |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02786810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.