<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/NCT03779906</url>
  </required_header>
  <id_info>
    <org_study_id>IOP-120</org_study_id>
    <nct_id>NCT03779906</nct_id>
  </id_info>
  <brief_title>Thyroid Function of Pediatric Subjects Following Isovue® Administration</brief_title>
  <official_title>A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bracco Diagnostics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bracco Diagnostics, Inc</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase IV prospective, multicenter, observational study to estimate the proportion&#xD;
      of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to&#xD;
      intravascular administration of ISOVUE for the required radiologic procedure as part of their&#xD;
      standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abnormal thyroid function</measure>
    <time_frame>Day 1 to 2 months</time_frame>
    <description>The primary outcome of this study is to evaluate the proportion of subjects, 0 to 3 years of age, developing abnormal thyroid function after administration of ISOVUE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypothyroidism</measure>
    <time_frame>Day 1 to 2 months</time_frame>
    <description>To evaluate the proportion of subjects, 0 to 3 years of age, with hypothyroidism regardless of the need for thyroid hormone therapy after administration of ISOVUE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thyroid hormone replacement therapy</measure>
    <time_frame>Day 1 to 12 months</time_frame>
    <description>The proportion of subjects initiated on thyroid hormone replacement therapy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1560</enrollment>
  <condition>Hypothyroidism</condition>
  <arm_group>
    <arm_group_label>ISOVUE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Isovue will be given to all subjects per the standard of clinical care.The specific iodine concentration and volume of ISOVUE used during the radiologic procedure will depend on the type of procedure and the standards in place at the site where the procedure is performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isovue</intervention_name>
    <description>Isovue will be given to all subjects per the standard of clinical care.</description>
    <arm_group_label>ISOVUE</arm_group_label>
    <other_name>IOPAMIDOL injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is male or female from 0 to 3 years of age;&#xD;
&#xD;
          -  Is scheduled to undergo a radiologic examination that requires intravascular&#xD;
             administration of ISOVUE as part of his/her standard of care;&#xD;
&#xD;
          -  Has normal baseline thyroid function tests (TSH, total T3, total T4, and fT4)&#xD;
             performed at a local laboratory with blood sample obtained within one week prior to&#xD;
             ISOVUE administration;&#xD;
&#xD;
          -  Written informed consent is obtained from the subject's parent(s) or legally&#xD;
             acceptable representative(s) (according to local regulations) who are willing to&#xD;
             comply with the protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has any known allergy to one or more of the ingredients of ISOVUE;&#xD;
&#xD;
          -  Has been diagnosed with congenital hypothyroidism;&#xD;
&#xD;
          -  Has undergone radiation treatments to the head or neck;&#xD;
&#xD;
          -  Is currently on thyroid replacement therapy;&#xD;
&#xD;
          -  Is on therapy with dopamine or any treatment which may affect the thyroid function&#xD;
             testing results;&#xD;
&#xD;
          -  Has been exposed to any topical iodinated product within 30 days prior to enrollment&#xD;
             in the present study;&#xD;
&#xD;
          -  Has been exposed to an iodinated contrast agent within 1 year prior to enrollment in&#xD;
             the present study, including any administration of iodinated contrast agents during&#xD;
             placement of a central line;&#xD;
&#xD;
          -  Has any medical condition or other circumstances which would significantly decrease&#xD;
             the chances of obtaining reliable data, achieving study objectives, or completing the&#xD;
             study and/or post-dose follow-up examinations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Luigia Storto, MD</last_name>
    <role>Study Director</role>
    <affiliation>Bracco Corporate</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital and Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypothyroidism</keyword>
  <keyword>ISOVUE</keyword>
  <keyword>Iodinated Contrast Agent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothyroidism</mesh_term>
  </condition_browse>
  <!-- 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/NCT03779906
org study id: IOP-120
nct id: NCT03779906
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase IV prospective, multicenter, observational study to estimate the proportion
      of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to
      intravascular administration of ISOVUE for the required radiologic procedure as part of their
      standard of care.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Abnormal thyroid function
time frame: Day 1 to 2 months
description: The primary outcome of this study is to evaluate the proportion of subjects, 0 to 3 years of age, developing abnormal thyroid function after administration of ISOVUE.
measure: Hypothyroidism
time frame: Day 1 to 2 months
description: To evaluate the proportion of subjects, 0 to 3 years of age, with hypothyroidism regardless of the need for thyroid hormone therapy after administration of ISOVUE.
measure: Thyroid hormone replacement therapy
time frame: Day 1 to 12 months
description: The proportion of subjects initiated on thyroid hormone replacement therapy.
arm group label: ISOVUE
arm group type: Experimental
description: Isovue will be given to all subjects per the standard of clinical care.The specific iodine concentration and volume of ISOVUE used during the radiologic procedure will depend on the type of procedure and the standards in place at the site where the procedure is performed.
intervention type: Drug
intervention name: Isovue
description: Isovue will be given to all subjects per the standard of clinical care.
arm group label: ISOVUE
other name: IOPAMIDOL injection
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Years
healthy volunteers: No
last name: Mary Luigia Storto, MD
role: Study Director
affiliation: Bracco Corporate
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypothyroidism