xml: <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/NCT05967117</url>
    </required_header>
    <id_info>
      <org_study_id>CTC42M014</org_study_id>
      <nct_id>NCT05967117</nct_id>
    </id_info>
    <brief_title>Chest CT Using Low-concentration Iodine Contrast Media</brief_title>
    <official_title>Chest CT Using Low-concentration Iodine Contrast Media - a Prospective Multicenter Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jung Im Jung</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Taejoon Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Seoul St. Mary's Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the quality of images when low-concentration iodine contrast&#xD;
        agents is used in chest CT with low tube voltage and if they can be used in routine imaging.&#xD;
  &#xD;
        The primary endpoint of the study was the quality of the image and comparison of chest CT by&#xD;
        using low and conventional concentration iodine contrast agents with low tube voltage and&#xD;
        chest CT by using the conventional concentration iodine contrast agents with the conventional&#xD;
        tube voltage; The secondary endpoint is optimizing chest CT protocol using an iodine contrast&#xD;
        agent.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        With persistent advances in computed tomography (CT) technology, there is a need for&#xD;
        continuous investigation and optimization of injection protocols. Intravenous contrast&#xD;
        enhancement in CT is affected by various interacting factors, which can be roughly divided&#xD;
        into 3 categories: patient, contrast medium and CT scanning. Over the last decade, evolutions&#xD;
        in technology has resulted in faster CTs with improved temporal and spatial resolutions;&#xD;
        newer techniques such as iterative reconstruction has enabled lower tube voltage (expressed&#xD;
        in units of peak kiloVolt, kVp) and lower dose CTs with less noise and preserved image&#xD;
        quality. As CT scanning is one of the major determinants of contrast enhancement at CT, such&#xD;
        technological advances in CT can be assumed to have invariably caused alterations in the&#xD;
        degree of contrast enhancement at CT. However, despite changes in CT scanning techniques,&#xD;
        recommended contrast injection protocol for chest CT with enhancement (CECT), including&#xD;
        concentration of iodine contrast material, have not changed over the last decade; for routine&#xD;
        chest CECT, the use of 300-350 mgI/ml iodine contrast material has been recommended without&#xD;
        definitely stating the precise reasons using that specific iodine concentration.&#xD;
  &#xD;
        Therefore, the aim of this study was to evaluate the image quality of low voltage chest CECT&#xD;
        using LCCM(Low-Concentration Iodinated Contrast Media.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>Phase 4</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anatomic depiction (including image sharpness)</measure>
      <time_frame>12 months after the CT scan (Chest contrast-enhanced CT is a 1-day procedure, but evaluating all the images will be done one year after the 1st CT scan.)</time_frame>
      <description>3 points scale qualitative analysis evaluated by two different radiologists (Poor, moderate, excellent)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Noise</measure>
      <time_frame>12 months after the CT scan</time_frame>
      <description>3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Contrast-related artifact</measure>
      <time_frame>12 months after the CT scan</time_frame>
      <description>3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall diagnostic acceptability</measure>
      <time_frame>12 months after the CT scan</time_frame>
      <description>5 points scale qualitative analysis evaluated by two different radiologists (Non-diagnostic, suboptimal, standard, better than standard, Excellent)</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">308</enrollment>
    <condition>Pulmonary Disease</condition>
    <arm_group>
      <arm_group_label>Chest CT evaluation (Administrate contrast media for CECT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the conventional tube voltage</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chest CT evaluation (Experimental 1)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the low tube voltage</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chest CT evaluation (Experimental 2)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who are planned chest contrast enhanced CT scan ; Low concentration iodine contrast agents with the low tube voltage)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chest CT evaluation (Experimental 3)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who are planned chest contrast enhanced CT scan; Ultra Low concentration iodine contrast agents with the low tube voltage)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Iohexol (320mgI/mL) with 120kVp</intervention_name>
      <description>Patient undergoing CT scan with 120kVp protocol and using Iobrix inj. 320 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.</description>
      <arm_group_label>Chest CT evaluation (Administrate contrast media for CECT)</arm_group_label>
      <other_name>Iobrix inj. 320</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Iohexol (320mgI/mL) with 100kVp</intervention_name>
      <description>Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 320 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.</description>
      <arm_group_label>Chest CT evaluation (Experimental 1)</arm_group_label>
      <other_name>Iobrix inj. 320</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Iohexol (270mgI/mL) with 100kVp</intervention_name>
      <description>Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 270 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.</description>
      <arm_group_label>Chest CT evaluation (Experimental 2)</arm_group_label>
      <other_name>Iobrix inj. 270</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Iohexol (240mgI/mL) with 100kVp</intervention_name>
      <description>Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 240 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.</description>
      <arm_group_label>Chest CT evaluation (Experimental 3)</arm_group_label>
      <other_name>Iobrix inj. 240</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who&#xD;
               underwent contrast-enhanced chest CT alone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Under the age of 18&#xD;
  &#xD;
            2. Cases where contrast-enhanced CT cannot be performed&#xD;
  &#xD;
            3. Heart failure&#xD;
  &#xD;
            4. Pregnancy&#xD;
  &#xD;
            5. If patients cannot voluntarily give written consent to participate in this clinical&#xD;
               trial&#xD;
  &#xD;
            6. In the case of an anatomical deformation that may interfere with image analysis in the&#xD;
               previous image&#xD;
  &#xD;
            7. Patients with a history of hypersensitivity to IOBRIX, components of IOBRIX, and&#xD;
               iodine-based drugs&#xD;
  &#xD;
            8. Patients with severe thyroid disease (Iodine may accumulate in the thyroid gland and&#xD;
               worsen symptoms.)&#xD;
  &#xD;
            9. Those who are judged unsuitable by the tester for other reasons Patients aged 19 years&#xD;
               or older, weighing less than 90 kg, and BMI less than 30 who underwent&#xD;
               contrast-enhanced chest CT alone&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jung Im Jung, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Seoul St. Mary's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jung IM Jung, MD, PhD</last_name>
      <phone>+822-2258-1456</phone>
      <email>jijung@catholic.ac.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul St. Mary's Hospital, The Catholic University of Korea</name>
        <address>
          <city>Seoul</city>
          <state>Seocho-gu</state>
          <zip>06591</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Department of Radiology</last_name>
        <phone>+822-2258-1456</phone>
        <email>oasis5noel@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
      <investigator_full_name>Jung Im Jung</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967117
  org study id: CTC42M014
  nct id: NCT05967117
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the quality of images when low-concentration iodine contrast
        agents is used in chest CT with low tube voltage and if they can be used in routine imaging.
  
        The primary endpoint of the study was the quality of the image and comparison of chest CT by
        using low and conventional concentration iodine contrast agents with low tube voltage and
        chest CT by using the conventional concentration iodine contrast agents with the conventional
        tube voltage; The secondary endpoint is optimizing chest CT protocol using an iodine contrast
        agent.
  With persistent advances in computed tomography (CT) technology, there is a need for
        continuous investigation and optimization of injection protocols. Intravenous contrast
        enhancement in CT is affected by various interacting factors, which can be roughly divided
        into 3 categories: patient, contrast medium and CT scanning. Over the last decade, evolutions
        in technology has resulted in faster CTs with improved temporal and spatial resolutions;
        newer techniques such as iterative reconstruction has enabled lower tube voltage (expressed
        in units of peak kiloVolt, kVp) and lower dose CTs with less noise and preserved image
        quality. As CT scanning is one of the major determinants of contrast enhancement at CT, such
        technological advances in CT can be assumed to have invariably caused alterations in the
        degree of contrast enhancement at CT. However, despite changes in CT scanning techniques,
        recommended contrast injection protocol for chest CT with enhancement (CECT), including
        concentration of iodine contrast material, have not changed over the last decade; for routine
        chest CECT, the use of 300-350 mgI/ml iodine contrast material has been recommended without
        definitely stating the precise reasons using that specific iodine concentration.
  
        Therefore, the aim of this study was to evaluate the image quality of low voltage chest CECT
        using LCCM(Low-Concentration Iodinated Contrast Media.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Anatomic depiction (including image sharpness)
  time frame: 12 months after the CT scan (Chest contrast-enhanced CT is a 1-day procedure, but evaluating all the images will be done one year after the 1st CT scan.)
  description: 3 points scale qualitative analysis evaluated by two different radiologists (Poor, moderate, excellent)
  measure: Noise
  time frame: 12 months after the CT scan
  description: 3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
  measure: Contrast-related artifact
  time frame: 12 months after the CT scan
  description: 3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
  measure: Overall diagnostic acceptability
  time frame: 12 months after the CT scan
  description: 5 points scale qualitative analysis evaluated by two different radiologists (Non-diagnostic, suboptimal, standard, better than standard, Excellent)
  arm group label: Chest CT evaluation (Administrate contrast media for CECT)
  arm group type: Active Comparator
  description: Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the conventional tube voltage
  arm group label: Chest CT evaluation (Experimental 1)
  arm group type: Experimental
  description: Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the low tube voltage
  arm group label: Chest CT evaluation (Experimental 2)
  arm group type: Experimental
  description: Patients who are planned chest contrast enhanced CT scan ; Low concentration iodine contrast agents with the low tube voltage)
  arm group label: Chest CT evaluation (Experimental 3)
  arm group type: Experimental
  description: Patients who are planned chest contrast enhanced CT scan; Ultra Low concentration iodine contrast agents with the low tube voltage)
  intervention type: Drug
  intervention name: Iohexol (320mgI/mL) with 120kVp
  description: Patient undergoing CT scan with 120kVp protocol and using Iobrix inj. 320 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
  arm group label: Chest CT evaluation (Administrate contrast media for CECT)
  other name: Iobrix inj. 320
  intervention type: Drug
  intervention name: Iohexol (320mgI/mL) with 100kVp
  description: Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 320 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
  arm group label: Chest CT evaluation (Experimental 1)
  other name: Iobrix inj. 320
  intervention type: Drug
  intervention name: Iohexol (270mgI/mL) with 100kVp
  description: Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 270 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
  arm group label: Chest CT evaluation (Experimental 2)
  other name: Iobrix inj. 270
  intervention type: Drug
  intervention name: Iohexol (240mgI/mL) with 100kVp
  description: Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 240 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
  arm group label: Chest CT evaluation (Experimental 3)
  other name: Iobrix inj. 240
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jung Im Jung, MD, PhD
  role: Study Chair
  affiliation: Seoul St. Mary's Hospital
  last name: Jung IM Jung, MD, PhD
  phone: +822-2258-1456
  email: jijung@catholic.ac.kr
  facility: 
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: Seoul St. Mary's Hospital
  investigator full name: Jung Im Jung
  investigator title: professor
  mesh term: Lung Diseases
  sharing ipd: No