Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration

NCT02986477 | Withdrawn DMC

• 1 other identifier: 00118038
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vesico-Ureteral Reflux

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Contrast Ultrasound

OTHER

Patients with vesicoureteral reflux will receive contrast ultrasound via Foley catheter for study of vesicoureteral reflux.

Other: Contrast Ultrasound

Interventions

Contrast Ultrasound OTHER

For diagnostic purposes, intravesicle administration of contrast ultrasound agent will be performed to study vesicoureteral reflux.

Contrast Ultrasound

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 8, 2016
• Study Start: January 1, 2017
• Primary Completion: January 9, 2018
• Study Completion: January 9, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share