<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/NCT03295656</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00025591</org_study_id>
    <nct_id>NCT03295656</nct_id>
  </id_info>
  <brief_title>Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis</brief_title>
  <official_title>Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of&#xD;
      acute appendicitis in children compared to conventional ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute appendicitis is the most common surgical emergency in children. Diagnostic evaluation&#xD;
      for possible appendicitis frequently leads to imaging studies. Magnetic resonance imaging&#xD;
      (MRI) and computed tomography (CT) are currently the gold-standard techniques for the&#xD;
      diagnosis or exclusion of acute appendicitis. However, these methods not always immediately&#xD;
      available; may require administration of intravenous contrast material with the potential for&#xD;
      allergic reactions and nephrotoxicity; and, in the case of CT, requires the administration of&#xD;
      ionizing radiation that is linked to the long-term development of radiation-induced cancers.&#xD;
      The current study will evaluate a potentially safer, radiation-free diagnostic method for&#xD;
      acute appendicitis, using contrast-enhanced ultrasound to provide a more accurate means of&#xD;
      visualizing the appendix than conventional US imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unanticipated delays.&#xD;
  </why_stopped>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>Phase 1</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>Contrast-enhanced ultrasound diagnosis of acute appendicitis</measure>
    <time_frame>One week</time_frame>
    <description>The efficacy of contrast-enhanced US in improving the diagnosis of acute appendicitis compared to conventional US will be assessed.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Appendicitis Acute</condition>
  <arm_group>
    <arm_group_label>IV Contrast-Enhanced US</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulfur hexafluoride lipid-type A microspheres</intervention_name>
    <description>Contrast-enhanced US imaging of the appendix</description>
    <arm_group_label>IV Contrast-Enhanced US</arm_group_label>
    <other_name>Lumason</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children who have had a conventional abdominal US study to rule out acute appendicitis&#xD;
             and are scheduled for an MRI or CT examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with serious comorbid conditions, including but not restricted to severe&#xD;
             cardiac, pulmonary, renal, or hepatic disease; prior bone marrow or solid organ&#xD;
             transplant; cancer; or presence of a ventriculoperitoneal shunt.&#xD;
&#xD;
          -  Children with an allergy to either the active or inactive components of Lumason.&#xD;
&#xD;
          -  Pregnant or nursing patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harriet Paltiel, MDCM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Harriet Joan Paltiel</investigator_full_name>
    <investigator_title>Associate Professor of Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</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/NCT03295656
org study id: IRB-P00025591
nct id: NCT03295656
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of
      acute appendicitis in children compared to conventional ultrasound.
Acute appendicitis is the most common surgical emergency in children. Diagnostic evaluation
      for possible appendicitis frequently leads to imaging studies. Magnetic resonance imaging
      (MRI) and computed tomography (CT) are currently the gold-standard techniques for the
      diagnosis or exclusion of acute appendicitis. However, these methods not always immediately
      available; may require administration of intravenous contrast material with the potential for
      allergic reactions and nephrotoxicity; and, in the case of CT, requires the administration of
      ionizing radiation that is linked to the long-term development of radiation-induced cancers.
      The current study will evaluate a potentially safer, radiation-free diagnostic method for
      acute appendicitis, using contrast-enhanced ultrasound to provide a more accurate means of
      visualizing the appendix than conventional US imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Contrast-enhanced ultrasound diagnosis of acute appendicitis
time frame: One week
description: The efficacy of contrast-enhanced US in improving the diagnosis of acute appendicitis compared to conventional US will be assessed.
arm group label: IV Contrast-Enhanced US
arm group type: Experimental
description: IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.
intervention type: Drug
intervention name: Sulfur hexafluoride lipid-type A microspheres
description: Contrast-enhanced US imaging of the appendix
arm group label: IV Contrast-Enhanced US
other name: Lumason
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Harriet Paltiel, MDCM
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Harriet Joan Paltiel
investigator title: Associate Professor of Radiology
mesh term: Appendicitis
sharing ipd: No