<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02986477</url>
  </required_header>
  <id_info>
    <org_study_id>00118038</org_study_id>
    <nct_id>NCT02986477</nct_id>
  </id_info>
  <brief_title>Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration</brief_title>
  <official_title>Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In children, specifically the intravesicle administration to study vesicoureteral reflux in&#xD;
      children already catheterized and scheduled for voiding cystourethrogram (VCUG).&#xD;
      Contrast-enhanced ultrasonography is a tremendous advancement from conventional B-mode and&#xD;
      color Doppler ultrasonography, as it permits noninvasive, non-ionizing delineation of&#xD;
      physiology and pathophysiology with higher resolution and accuracy in children. The technique&#xD;
      is particularly useful in pediatric population whose lifetime risk of cancer significantly&#xD;
      increases with higher frequency of ionizing radiation. Voiding cystourethrogram is a&#xD;
      fluoroscopy technique that can study reflux real time but at the risk of radiation side&#xD;
      effects. In this regard, intravesicle administration of ultrasound contrast agent can help&#xD;
      avoid radiation in children and potentially replace the conventionally used voiding&#xD;
      cystourethrogram.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most commonly used genitourinary application of ultrasound contrast agent is for the&#xD;
      diagnosis of vesicoureteral reflux via intra-vesicle administration of contrast agent. The&#xD;
      utility of ultrasound contrast agent in contrast-enhanced voiding urosonography is well&#xD;
      established and published over two decades (Darge 2002, Darge 2008, Darge 2010). As with&#xD;
      other applications of ultrasound contrast agents, the method offers the advantages of no&#xD;
      radiation, low cost, excellent anatomic detail, and higher sensitivity for reflux detection&#xD;
      than VCUG. The most comprehensive study to detail the safety profile of intravesicle&#xD;
      ultrasound contrast is by Papadopoulou et al. (Papadopoulou, Ntoulia et al. 2014) which&#xD;
      described a total of 1,010 children (563 girls, 447 boys) with a mean age of 2.9 years. No&#xD;
      adverse events were reported at 1 hour after exam. Follow-up phone interviews revealed no&#xD;
      adverse events in the majority (973 of 1,010). The remaining 37 children experienced mild&#xD;
      symptoms including dysuria (n=26) and urinary retention (n=2) which may have been related to&#xD;
      catheterization rather than the contrast agent. A recent European survey at 29 centers&#xD;
      evaluating the use of ultrasound contrast agent in 4,131 children for pediatric reflux&#xD;
      diagnosis reported no adverse events (Riccabona 2012).&#xD;
&#xD;
      The procedure consists of pre-contrast, post-contrast, voiding phase, and post-void depiction&#xD;
      of the kidneys, ureters, bladder, and transperineal scan of the urethra, for identification&#xD;
      of potential ectopic ureters (Darge 2008, Duran, del Riego et al. 2012) that can easily be&#xD;
      missed on non-distended ureters on CT, MRI, or radionuclide imaging. The two primary methods&#xD;
      of contrast injection includes direct injection into a partially filled bladder (Darge 2008)&#xD;
      and another using a saline bag for subsequent drip infusion via the catheter into the bladder&#xD;
      (Back, Edgar et al. 2015).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI leaving institution&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 9, 2018</completion_date>
  <primary_completion_date type="Actual">January 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration</measure>
    <time_frame>10 years</time_frame>
    <description>The presence of vesicoureteral reflux is assessed as the primary outcome measure.&#xD;
Qualitative evaluation is performed to assess the presence of contrast within the collecting systems, which then correlates with vesicoureteral reflux.&#xD;
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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Vesico-Ureteral Reflux</condition>
  <arm_group>
    <arm_group_label>Contrast Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with vesicoureteral reflux will receive contrast ultrasound via Foley catheter for study of vesicoureteral reflux.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Contrast Ultrasound</intervention_name>
    <description>For diagnostic purposes, intravesicle administration of contrast ultrasound agent will be performed to study vesicoureteral reflux.</description>
    <arm_group_label>Contrast Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients aged 0-17 years undergoing an ultrasound for a clinical&#xD;
             indication at the Johns Hopkins Hospital&#xD;
&#xD;
          -  Willing to either extend a previously scheduled clinically indicated voiding&#xD;
             cystourethrogram&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac&#xD;
             shunts&#xD;
&#xD;
          -  History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere&#xD;
             components or to any of the inactive ingredients in LUMASON. Inactive ingredients&#xD;
             include 1,2-Dipalmitoyl-sn-glycero-3-phosphoglycerol, sodium salt (DPPG), a minor&#xD;
             (1-2%) component normally present in most cell membranes,&#xD;
             Diasteroylphosphatidylcholine (DSPC), a commonly used synthetic phospholipids, and&#xD;
             palmitic acid, the most commonly found fatty acid in animals.&#xD;
&#xD;
          -  Patient subjects in unstable clinical condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>January 22, 2018</last_update_submitted>
  <last_update_submitted_qc>January 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vesico-Ureteral Reflux</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02986477
org study id: 00118038
nct id: NCT02986477
lead sponsor: 
has dmc: Yes
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.
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration
time frame: 10 years
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.
arm group label: Contrast Ultrasound
arm group type: Other
description: Patients with vesicoureteral reflux will receive contrast ultrasound via Foley catheter for study of vesicoureteral reflux.
intervention type: Other
intervention name: Contrast Ultrasound
description: For diagnostic purposes, intravesicle administration of contrast ultrasound agent will be performed to study vesicoureteral reflux.
arm group label: Contrast Ultrasound
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Vesico-Ureteral Reflux
sharing ipd: No