<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/NCT01693796</url>
  </required_header>
  <id_info>
    <org_study_id>2010-A01118-31</org_study_id>
    <secondary_id>2010-09</secondary_id>
    <nct_id>NCT01693796</nct_id>
  </id_info>
  <brief_title>Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease</brief_title>
  <official_title>Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the average risk for thyroid irradiation for any&#xD;
      type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv,&#xD;
      adjusted to the measured thyroid volume and to the patient's age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>exposure to radiation measure</measure>
    <time_frame>2 YEARS</time_frame>
    <description>To determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>exposure to radiation measure</measure>
    <time_frame>2 YEARS</time_frame>
    <description>Fit the dose of average irradiation of the thyroid during the catheterizations to the thyroïdien volume</description>
  </secondary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Cardiac Catheterizations</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood and urine samples ; Echography</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion of any patient (&lt; 18 year-old) with congenital heart disease undergoing one&#xD;
             or more cardiac catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion of patients with any type of thyroid dissease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BERNARD BELAIGUES</last_name>
    <role>Study Chair</role>
    <affiliation>Assistance Publique hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>April 5, 2011</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</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">July 28, 2023</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>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT01693796
org study id: 2010-A01118-31
secondary id: 2010-09
nct id: NCT01693796
lead sponsor: 
has dmc: No
The purpose of this study is to determine the average risk for thyroid irradiation for any
      type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv,
      adjusted to the measured thyroid volume and to the patient's age.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: exposure to radiation measure
time frame: 2 YEARS
description: To determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.
measure: exposure to radiation measure
time frame: 2 YEARS
description: Fit the dose of average irradiation of the thyroid during the catheterizations to the thyroïdien volume
intervention type: Other
intervention name: blood and urine samples ; Echography
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: BERNARD BELAIGUES
role: Study Chair
affiliation: Assistance Publique hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital