<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/NCT03305978</url>
  </required_header>
  <id_info>
    <org_study_id>38RC17.132</org_study_id>
    <nct_id>NCT03305978</nct_id>
  </id_info>
  <brief_title>Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.</brief_title>
  <acronym>npUBD</acronym>
  <official_title>Detection of Pulmonary Nodules: Comparison of Ultra-low-dose Chest CT (Approaching a Two Views Chest X-ray Radiation) and Standard Low Dose CT. A Monocentric, Prospective, Non-randomized, Comparative, Open-label Study With Blind Reading of the Judgment Criteria.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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>
      Lung cancer screening programs are still discussed in Europe today, and one of the concern is&#xD;
      radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study&#xD;
      is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard&#xD;
      low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule&#xD;
      characterization and smoking associated findings (emphysema, bronchial abnormalities and&#xD;
      coronary calcifications).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An additional Ultra Low Dose CT, approaching 0.2mSv, will be performed in consenting patients&#xD;
      referred for non enhanced chest CT in our Revolution CT scanner (GE Healthcare®).The dose&#xD;
      delivered with the two acquisitions is still lower than the french diagnostic reference&#xD;
      level. Standard CT is interpreted and a report is sent to the referent physician as usual.&#xD;
      Then the two acquisitions are read over time by two independent radiologists, blinded over&#xD;
      judgment criterias. In case of discordance, an other radiologist will arbitrate. We hope to&#xD;
      validate our Ultra low dose chest CT protocol, which is more than 10 times less radiating&#xD;
      than a standard low dose CT, as a sensitive tool to detect lung nodules.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Major Patient Addressed for Thoracic CT without Injection of Contrast</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>blinding evaluation of criteria</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Ultra low dose CT lung nodule detection sensibility</measure>
    <time_frame>22 months</time_frame>
    <description>Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultra low dose CT diagnostic performances of lung nodule detection</measure>
    <time_frame>22 months</time_frame>
    <description>true positives, false positives, true negatives, false negatives, positive predictive value, negative predictive value, specificity, of ≥4mm lung nodules detection within ultra low dose chest CT versus standard low dose chest CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT</measure>
    <time_frame>22 months</time_frame>
    <description>comparison of size, density, type (true nodule or intrapulmonary ganglion) of ≥4mm lung nodule between ultra low dose and standard low dose chest CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultra low dose CT inter-observer reproducibility</measure>
    <time_frame>22 months</time_frame>
    <description>inter observer reproducibility for size, density and type of ≥4mm lung nodule detected in ultra low dose CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT</measure>
    <time_frame>22 months</time_frame>
    <description>analysis of subjects characteristics (age, gender, body mass index), ≥4mm nodule location, and ≥4 mm nodule size on detection between ultra low dose and standard low dose chest CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT</measure>
    <time_frame>22 months</time_frame>
    <description>comparison of emphysema detection, type (centrilobular, paraseptal, panlobular, bullous) and distribution between ultra low dose and standard low dose chest CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT</measure>
    <time_frame>22 months</time_frame>
    <description>Comparison of Weston scores between ultra low dose and standard low dose chest CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT</measure>
    <time_frame>22 months</time_frame>
    <description>comparison of detection of bronchial thickening or dilatation between ultra low dose and standard low dose chest CT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Smoking</condition>
  <condition>Radiation Exposure</condition>
  <arm_group>
    <arm_group_label>Ultra low dose chest CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose chest CT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultra low dose chest CT</intervention_name>
    <description>An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.</description>
    <arm_group_label>Ultra low dose chest CT</arm_group_label>
    <other_name>Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR V</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low dose chest CT</intervention_name>
    <description>standard diagnostic low dose chest CT</description>
    <arm_group_label>Low dose chest CT</arm_group_label>
    <other_name>Revolution CT (GE Healthcare)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          1. Patients referred for non enhanced chest CT for following indications :&#xD;
&#xD;
               -  lung nodule search or control&#xD;
&#xD;
               -  nodular abnormality on chest X ray&#xD;
&#xD;
               -  statement of COPD or emphysema&#xD;
&#xD;
               -  asbestos exposure&#xD;
&#xD;
               -  nodule localization before radio frequency ablation&#xD;
&#xD;
               -  assessment of disease extent of an extra thoracic cancer (in case of iodinated&#xD;
                  intravenous contrast agent contraindication)&#xD;
&#xD;
               -  statement before extrathoracic transplantation (in case of iodinated intravenous&#xD;
                  contrast agent contraindication)&#xD;
&#xD;
          2. Affiliated with the french social security&#xD;
&#xD;
          3. Who signed consent&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          1. Inability to lie down and still during the examination&#xD;
&#xD;
          2. Inability to hold breath more than 5 seconds&#xD;
&#xD;
          3. Pneumonia in the last 3 months&#xD;
&#xD;
          4. Body mass index more than 35kg/m²&#xD;
&#xD;
          5. exclusion period of another interventionnal study&#xD;
&#xD;
          6. referred for articles L1121-5 to L1121-8 of french public health code&#xD;
&#xD;
          7. Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilbert Ferretti, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultra low dose chest CT</keyword>
  <keyword>lung cancer screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Pulmonary Nodules</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
    <mesh_term>Selamectin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03305978
org study id: 38RC17.132
nct id: NCT03305978
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lung cancer screening programs are still discussed in Europe today, and one of the concern is
      radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study
      is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard
      low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule
      characterization and smoking associated findings (emphysema, bronchial abnormalities and
      coronary calcifications).
An additional Ultra Low Dose CT, approaching 0.2mSv, will be performed in consenting patients
      referred for non enhanced chest CT in our Revolution CT scanner (GE Healthcare®).The dose
      delivered with the two acquisitions is still lower than the french diagnostic reference
      level. Standard CT is interpreted and a report is sent to the referent physician as usual.
      Then the two acquisitions are read over time by two independent radiologists, blinded over
      judgment criterias. In case of discordance, an other radiologist will arbitrate. We hope to
      validate our Ultra low dose chest CT protocol, which is more than 10 times less radiating
      than a standard low dose CT, as a sensitive tool to detect lung nodules.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Major Patient Addressed for Thoracic CT without Injection of Contrast
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: blinding evaluation of criteria
measure: Ultra low dose CT lung nodule detection sensibility
time frame: 22 months
description: Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT
measure: Ultra low dose CT diagnostic performances of lung nodule detection
time frame: 22 months
description: true positives, false positives, true negatives, false negatives, positive predictive value, negative predictive value, specificity, of ≥4mm lung nodules detection within ultra low dose chest CT versus standard low dose chest CT
measure: Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT
time frame: 22 months
description: comparison of size, density, type (true nodule or intrapulmonary ganglion) of ≥4mm lung nodule between ultra low dose and standard low dose chest CT
measure: Ultra low dose CT inter-observer reproducibility
time frame: 22 months
description: inter observer reproducibility for size, density and type of ≥4mm lung nodule detected in ultra low dose CT
measure: Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT
time frame: 22 months
description: analysis of subjects characteristics (age, gender, body mass index), ≥4mm nodule location, and ≥4 mm nodule size on detection between ultra low dose and standard low dose chest CT
measure: Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT
time frame: 22 months
description: comparison of emphysema detection, type (centrilobular, paraseptal, panlobular, bullous) and distribution between ultra low dose and standard low dose chest CT
measure: Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT
time frame: 22 months
description: Comparison of Weston scores between ultra low dose and standard low dose chest CT
measure: Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT
time frame: 22 months
description: comparison of detection of bronchial thickening or dilatation between ultra low dose and standard low dose chest CT
arm group label: Ultra low dose chest CT
arm group type: Experimental
arm group label: Low dose chest CT
arm group type: Active Comparator
intervention type: Device
intervention name: Ultra low dose chest CT
description: An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.
arm group label: Ultra low dose chest CT
other name: Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR V
intervention type: Device
intervention name: Low dose chest CT
description: standard diagnostic low dose chest CT
arm group label: Low dose chest CT
other name: Revolution CT (GE Healthcare)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilbert Ferretti, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Pulmonary Nodules
mesh term: Ivermectin
mesh term: Selamectin
sharing ipd: No