Vesico-Ureteral Reflux Clinical Trial
Official title:
Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration
Verified date | January 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In children, specifically the intravesicle administration to study vesicoureteral reflux in children already catheterized and scheduled for voiding cystourethrogram (VCUG). Contrast-enhanced ultrasonography is a tremendous advancement from conventional B-mode and color Doppler ultrasonography, as it permits noninvasive, non-ionizing delineation of physiology and pathophysiology with higher resolution and accuracy in children. The technique is particularly useful in pediatric population whose lifetime risk of cancer significantly increases with higher frequency of ionizing radiation. Voiding cystourethrogram is a fluoroscopy technique that can study reflux real time but at the risk of radiation side effects. In this regard, intravesicle administration of ultrasound contrast agent can help avoid radiation in children and potentially replace the conventionally used voiding cystourethrogram.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 9, 2018 |
Est. primary completion date | January 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Male or female patients aged 0-17 years undergoing an ultrasound for a clinical indication at the Johns Hopkins Hospital - Willing to either extend a previously scheduled clinically indicated voiding cystourethrogram Exclusion Criteria: - Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts - History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON. Inactive ingredients include 1,2-Dipalmitoyl-sn-glycero-3-phosphoglycerol, sodium salt (DPPG), a minor (1-2%) component normally present in most cell membranes, Diasteroylphosphatidylcholine (DSPC), a commonly used synthetic phospholipids, and palmitic acid, the most commonly found fatty acid in animals. - Patient subjects in unstable clinical condition. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Johns Hopkins University |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration | The presence of vesicoureteral reflux is assessed as the primary outcome measure. Qualitative evaluation is performed to assess the presence of contrast within the collecting systems, which then correlates with vesicoureteral reflux. Since this is a qualitative evaluation based on the acquired radiologic images, there is no unit, but the degree of vesicoureteral reflux is assessed. Vesicoureteral reflux is graded into I to V grades based on the severity. |
10 years |
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