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

Primary Purpose

Vesico-Ureteral Reflux

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contrast Ultrasound
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vesico-Ureteral Reflux

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Contrast Ultrasound

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2016
    Last Updated
    January 22, 2018
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02986477
    Brief Title
    Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration
    Official Title
    Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI leaving institution
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    January 9, 2018 (Actual)
    Study Completion Date
    January 9, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    The most commonly used genitourinary application of ultrasound contrast agent is for the diagnosis of vesicoureteral reflux via intra-vesicle administration of contrast agent. The utility of ultrasound contrast agent in contrast-enhanced voiding urosonography is well established and published over two decades (Darge 2002, Darge 2008, Darge 2010). As with other applications of ultrasound contrast agents, the method offers the advantages of no radiation, low cost, excellent anatomic detail, and higher sensitivity for reflux detection than VCUG. The most comprehensive study to detail the safety profile of intravesicle ultrasound contrast is by Papadopoulou et al. (Papadopoulou, Ntoulia et al. 2014) which described a total of 1,010 children (563 girls, 447 boys) with a mean age of 2.9 years. No adverse events were reported at 1 hour after exam. Follow-up phone interviews revealed no adverse events in the majority (973 of 1,010). The remaining 37 children experienced mild symptoms including dysuria (n=26) and urinary retention (n=2) which may have been related to catheterization rather than the contrast agent. A recent European survey at 29 centers evaluating the use of ultrasound contrast agent in 4,131 children for pediatric reflux diagnosis reported no adverse events (Riccabona 2012). The procedure consists of pre-contrast, post-contrast, voiding phase, and post-void depiction of the kidneys, ureters, bladder, and transperineal scan of the urethra, for identification of potential ectopic ureters (Darge 2008, Duran, del Riego et al. 2012) that can easily be missed on non-distended ureters on CT, MRI, or radionuclide imaging. The two primary methods of contrast injection includes direct injection into a partially filled bladder (Darge 2008) and another using a saline bag for subsequent drip infusion via the catheter into the bladder (Back, Edgar et al. 2015).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vesico-Ureteral Reflux

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Contrast Ultrasound
    Arm Type
    Other
    Arm Description
    Patients with vesicoureteral reflux will receive contrast ultrasound via Foley catheter for study of vesicoureteral reflux.
    Intervention Type
    Other
    Intervention Name(s)
    Contrast Ultrasound
    Intervention Description
    For diagnostic purposes, intravesicle administration of contrast ultrasound agent will be performed to study vesicoureteral reflux.
    Primary Outcome Measure Information:
    Title
    Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration
    Description
    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.
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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