<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/NCT01672996</url>
  </required_header>
  <id_info>
    <org_study_id>GE-145-004</org_study_id>
    <nct_id>NCT01672996</nct_id>
  </id_info>
  <brief_title>Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers</brief_title>
  <official_title>A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Physician Reference Laboratory</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quintiles, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GE Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To&#xD;
      evaluate the safety and tolerability of low concentration Ioforminol Injections. Study&#xD;
      recruits healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).</measure>
    <time_frame>Within 5 minutes after administration for either Ioforminol or Iopamidol.</time_frame>
    <description>Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).</measure>
    <time_frame>Within 5 minutes after administration for either Ioforminol or Iopamidol.</time_frame>
    <description>Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).</measure>
    <time_frame>Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.</time_frame>
    <description>Recording the occurrence of treatment emergent adverse events (TEAE).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Arm 1 - Ioforminol 160mgI/mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single administration of Ioforminol 160mgI/mL given to the subject.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 - Ioforminol 200mgI/mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Given as a single administration to the subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3 - Iopamidol 300mgI/mL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Given as a single administration to the subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ioforminol 160 mgI/mL</intervention_name>
    <description>Given as s single administration to the subject</description>
    <arm_group_label>Arm 1 - Ioforminol 160mgI/mL</arm_group_label>
    <other_name>Ioforminol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ioforminol 200 mgI/mL</intervention_name>
    <description>Given as a single administration to the subject</description>
    <arm_group_label>Arm 2 - Ioforminol 200mgI/mL</arm_group_label>
    <other_name>Ioforminol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iopamidol 300 mgI/mL</intervention_name>
    <description>Given as a single administration to the subject</description>
    <arm_group_label>Arm 3 - Iopamidol 300mgI/mL</arm_group_label>
    <other_name>Iopamidol</other_name>
    <other_name>Isovue 300</other_name>
    <other_name>Isovue</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females between 18 and 50 years of age.&#xD;
&#xD;
          -  The subject has a maximum abdominal circumference of 120 cm or less.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine&#xD;
             or any iodinated-based contrast agent or with history of multiple allergies (i.e.,&#xD;
             foods, pets, medications, etc).&#xD;
&#xD;
          -  The subject has chronic renal insufficiency (estimated glomerular filtration rate&#xD;
             [eGFR] &lt;60 mg/dL) as measured at the screening visit.&#xD;
&#xD;
          -  The subject is pregnant or breast-feeding.&#xD;
&#xD;
          -  The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning&#xD;
             thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.&#xD;
&#xD;
          -  The subject has severe liver or hematologic diseases (sickle cell disease or multiple&#xD;
             myeloma), or immunodeficiency.&#xD;
&#xD;
          -  The subject is taking metformin (e.g., Glucophage®) therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rubin Sheng, MD</last_name>
    <role>Study Director</role>
    <affiliation>GE Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GE Healthcare</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>January 17, 2014</results_first_submitted>
  <results_first_submitted_qc>January 17, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 3, 2014</results_first_posted>
  <last_update_submitted>May 13, 2014</last_update_submitted>
  <last_update_submitted_qc>May 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Use in Abdominal</keyword>
  <keyword>Contrast Enhanced</keyword>
  <keyword>Computed Tomography</keyword>
  <keyword>Optimize concentration</keyword>
  <keyword>dosage of Ioforminol Injection</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm 1 - Ioforminol 160mgI/mL</title>
          <description>Single administration of Ioforminol 160mgI/mL given to the subject.&#xD;
Ioforminol 160 mgI/mL: Given as s single administration to the subject</description>
        </group>
        <group group_id="P2">
          <title>Arm 2 - Ioforminol 200mgI/mL</title>
          <description>Given as a single administration to the subject&#xD;
Ioforminol 200 mgI/mL: Given as a single administration to the subject</description>
        </group>
        <group group_id="P3">
          <title>Arm 3 - Iopamidol 300mgI/mL</title>
          <description>Given as a single administration to the subject&#xD;
Iopamidol 300 mgI/mL: Given as a single administration to the subject</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg</title>
          <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/kg.</description>
        </group>
        <group group_id="B2">
          <title>Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg</title>
          <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/kg.</description>
        </group>
        <group group_id="B3">
          <title>Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg</title>
          <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/kg.</description>
        </group>
        <group group_id="B4">
          <title>Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg</title>
          <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
        </group>
        <group group_id="B5">
          <title>Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg</title>
          <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/Kg</description>
        </group>
        <group group_id="B6">
          <title>Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg</title>
          <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/Kg</description>
        </group>
        <group group_id="B7">
          <title>Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg</title>
          <description>Iopamidol 300 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="10"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).</title>
        <description>Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.</description>
        <time_frame>Within 5 minutes after administration for either Ioforminol or Iopamidol.</time_frame>
        <population>Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/kg.</description>
          </group>
          <group group_id="O2">
            <title>Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/kg.</description>
          </group>
          <group group_id="O3">
            <title>Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/kg.</description>
          </group>
          <group group_id="O4">
            <title>Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
          </group>
          <group group_id="O5">
            <title>Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/Kg</description>
          </group>
          <group group_id="O6">
            <title>Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/Kg</description>
          </group>
          <group group_id="O7">
            <title>Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg</title>
            <description>Iopamidol 300 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).</title>
          <description>Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.</description>
          <population>Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.</population>
          <units>Hounsfield Units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168" spread="41.0"/>
                    <measurement group_id="O2" value="261" spread="56.5"/>
                    <measurement group_id="O3" value="345" spread="30.7"/>
                    <measurement group_id="O4" value="341" spread="33.6"/>
                    <measurement group_id="O5" value="357" spread="30.1"/>
                    <measurement group_id="O6" value="365" spread="67.7"/>
                    <measurement group_id="O7" value="331" spread="53.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).</title>
        <description>Recording the occurrence of treatment emergent adverse events (TEAE).</description>
        <time_frame>Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.</time_frame>
        <population>These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/kg.</description>
          </group>
          <group group_id="O2">
            <title>Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/kg.</description>
          </group>
          <group group_id="O3">
            <title>Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/kg.</description>
          </group>
          <group group_id="O4">
            <title>Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
          </group>
          <group group_id="O5">
            <title>Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/Kg</description>
          </group>
          <group group_id="O6">
            <title>Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/Kg</description>
          </group>
          <group group_id="O7">
            <title>Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg</title>
            <description>Iopamidol 300 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).</title>
          <description>Recording the occurrence of treatment emergent adverse events (TEAE).</description>
          <population>These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).</population>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Treatment Emergent Adverse Events (TEAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment Emergent Adverse Events-IMP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intensity-Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withdrawals due to Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).</title>
        <description>Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.</description>
        <time_frame>Within 5 minutes after administration for either Ioforminol or Iopamidol.</time_frame>
        <population>Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/kg.</description>
          </group>
          <group group_id="O2">
            <title>Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/kg.</description>
          </group>
          <group group_id="O3">
            <title>Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg</title>
            <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/kg.</description>
          </group>
          <group group_id="O4">
            <title>Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
          </group>
          <group group_id="O5">
            <title>Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/Kg</description>
          </group>
          <group group_id="O6">
            <title>Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg</title>
            <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/Kg</description>
          </group>
          <group group_id="O7">
            <title>Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg</title>
            <description>Iopamidol 300 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).</title>
          <description>Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.</description>
          <population>Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.</population>
          <units>Hounsfield Units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191" spread="34.6"/>
                    <measurement group_id="O2" value="230" spread="40.2"/>
                    <measurement group_id="O3" value="212" spread="22.2"/>
                    <measurement group_id="O4" value="261" spread="37.7"/>
                    <measurement group_id="O5" value="246" spread="36.6"/>
                    <measurement group_id="O6" value="240" spread="49.4"/>
                    <measurement group_id="O7" value="257" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 72 hours post Ioforminal or Iopamidol administration.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg</title>
          <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/kg.</description>
        </group>
        <group group_id="E2">
          <title>Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg</title>
          <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/kg.</description>
        </group>
        <group group_id="E3">
          <title>Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg</title>
          <description>Ioforminol 160 mgI/mL: Given as s single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/kg.</description>
        </group>
        <group group_id="E4">
          <title>Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg</title>
          <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
        </group>
        <group group_id="E5">
          <title>Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg</title>
          <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.5mL/Kg</description>
        </group>
        <group group_id="E6">
          <title>Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg</title>
          <description>Ioforminol 200 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 2.0mL/Kg</description>
        </group>
        <group group_id="E7">
          <title>Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg</title>
          <description>Iopamidol 300 mgI/mL: Given as a single administration to the subject.&#xD;
Dosing the Subject at 1.0mL/Kg</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Feeling Hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="10"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rubin Sheng, MD</name_or_title>
      <organization>GE Healthcare</organization>
      <phone>609-514-6899</phone>
      <email>Rubin.Sheng@ge.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01672996
org study id: GE-145-004
nct id: NCT01672996
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To
      evaluate the safety and tolerability of low concentration Ioforminol Injections. Study
      recruits healthy volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
description: Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
measure: Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
description: Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
measure: Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
time frame: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.
description: Recording the occurrence of treatment emergent adverse events (TEAE).
arm group label: Arm 1 - Ioforminol 160mgI/mL
arm group type: Experimental
description: Single administration of Ioforminol 160mgI/mL given to the subject.
arm group label: Arm 2 - Ioforminol 200mgI/mL
arm group type: Experimental
description: Given as a single administration to the subject
arm group label: Arm 3 - Iopamidol 300mgI/mL
arm group type: Active Comparator
description: Given as a single administration to the subject
intervention type: Drug
intervention name: Ioforminol 160 mgI/mL
description: Given as s single administration to the subject
arm group label: Arm 1 - Ioforminol 160mgI/mL
other name: Ioforminol
intervention type: Drug
intervention name: Ioforminol 200 mgI/mL
description: Given as a single administration to the subject
arm group label: Arm 2 - Ioforminol 200mgI/mL
other name: Ioforminol
intervention type: Drug
intervention name: Iopamidol 300 mgI/mL
description: Given as a single administration to the subject
arm group label: Arm 3 - Iopamidol 300mgI/mL
other name: Iopamidol
other name: Isovue 300
other name: Isovue
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rubin Sheng, MD
role: Study Director
affiliation: GE Healthcare
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 