<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/NCT04453059</url>
  </required_header>
  <id_info>
    <org_study_id>IOP-121</org_study_id>
    <nct_id>NCT04453059</nct_id>
  </id_info>
  <brief_title>Study With Oral Isovue in Abdominopelvic CT</brief_title>
  <official_title>A Phase IIIB, Multicenter Study With Oral Administration of Isovue-300 for Opacification and Delineation of the Gastrointestinal (GI) Tract in Abdominopelvic Computed Tomography (CT)</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 retrospective clinical study with prospectively designed blinded evaluation of CT&#xD;
      images in adult and pediatric patients who underwent CT examinations of the abdomen and&#xD;
      pelvis and were orally administered a solution of Isovue-300 to opacify the GI tract to&#xD;
      distinguish it from adjacent abdominal and pelvic structures. The study will collect already&#xD;
      existing data, such as demographic data, adverse events and CT images, for all&#xD;
      chronologically enrolled patients who meet the inclusion/exclusion criteria prospectively&#xD;
      defined in this protocol&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2021</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with adequate visualization of anatomic delineation of the GI tract</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">218</enrollment>
  <condition>Patients Requiring Abdominopelvic CT With Oral Administration of Contrast</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iopamidol</intervention_name>
    <description>Previously administered Isovue-300 (300 mgI/mL) PO at a dilution of 2-3% (6-9 mgI/mL)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult and pediatric patients who have previously undergone CT examination of the abdomen&#xD;
        and pelvis with oral administration of Isovue-300 (2-3% concentration) as part of their&#xD;
        clinical work-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients will be included in the study if:&#xD;
&#xD;
          -  Demographic and safety data are available for analysis&#xD;
&#xD;
          -  Complete set of CT images performed after oral administration of Isovue-300 are&#xD;
             available for assessment&#xD;
&#xD;
          -  Isovue-300 was orally administered during an interval time of 60-20 minutes before the&#xD;
             CT scanning.&#xD;
&#xD;
        Patients will be excluded from the study if:&#xD;
&#xD;
          -  Oral contrast agent received within 1 week prior to the CT scan&#xD;
&#xD;
          -  Undergone any abdominopelvic surgery procedure that resulted in alteration of the&#xD;
             bowel transit time prior to the CT exam&#xD;
&#xD;
          -  CT exam with oral administration of Isovue was performed because of a known or&#xD;
             suspected condition of bowel obstruction&#xD;
&#xD;
          -  Patient did not actively drink the contrast solution.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Akron Children's Hospital</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Isovue</keyword>
  <!-- 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/NCT04453059
org study id: IOP-121
nct id: NCT04453059
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a retrospective clinical study with prospectively designed blinded evaluation of CT
      images in adult and pediatric patients who underwent CT examinations of the abdomen and
      pelvis and were orally administered a solution of Isovue-300 to opacify the GI tract to
      distinguish it from adjacent abdominal and pelvic structures. The study will collect already
      existing data, such as demographic data, adverse events and CT images, for all
      chronologically enrolled patients who meet the inclusion/exclusion criteria prospectively
      defined in this protocol
observational model: Other
time perspective: Retrospective
measure: Proportion of patients with adequate visualization of anatomic delineation of the GI tract
time frame: through study completion, an average of 1 year
intervention type: Drug
intervention name: Iopamidol
description: Previously administered Isovue-300 (300 mgI/mL) PO at a dilution of 2-3% (6-9 mgI/mL)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor