<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/NCT01720186</url>
  </required_header>
  <id_info>
    <org_study_id>12POUM01</org_study_id>
    <nct_id>NCT01720186</nct_id>
  </id_info>
  <brief_title>Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer</brief_title>
  <acronym>SPI COHERENCE</acronym>
  <official_title>Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Claudius Regaud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Claudius Regaud</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study, single-center, prospective, open-label, to assess the acceptability&#xD;
      and performance of the experimental medical device (SPI) used during an imaging examination&#xD;
      (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its&#xD;
      own control, since the imaging examination will be synchronized simultaneously with the two&#xD;
      systems: tested Medical Device (SPI) and reference Medical Device(RPM).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the PET/CT synchronized exam with SPI device (&quot;success&quot; or &quot;failure&quot; )</measure>
    <time_frame>2 years</time_frame>
    <description>feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment):&#xD;
Tolerance / acceptability of the patient to breathe into SPI throughout the examination)&#xD;
Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100).&#xD;
Accuracy of detection of inspiratory peak amplitudes with SPI medical device: by measuring dtSpi (dtSpi = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle).&#xD;
Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm</measure>
    <time_frame>2 years</time_frame>
    <description>dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of BTVrpm (= biologic tumoral volume)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Lung Nodule</condition>
  <arm_group>
    <arm_group_label>SPI Medical device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>reference medical device : RPM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/CT 4D imaging in a synchronized mode centered on the thorax.</intervention_name>
    <arm_group_label>SPI Medical device</arm_group_label>
    <arm_group_label>reference medical device : RPM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology&#xD;
             ; this indication is consistent with the Standard Options Recommendations or was&#xD;
             validated during Multidisciplinary Consultation Meeting :&#xD;
&#xD;
               -  Either an extension assessment of non-small cell lung cancer;&#xD;
&#xD;
               -  Either the characterization of single pulmonary nodule; Or - the definition of&#xD;
                  the target volume in radiotherapy.&#xD;
&#xD;
          2. Patient who meets the following criteria to be eligible for an PET/CT imaging:&#xD;
&#xD;
               -  Patient able to maintain a supine position for 60 minutes&#xD;
&#xD;
               -  Patient with no bronchopulmonary infection and with no upper aero digestive tract&#xD;
                  acute infection in progress (increased risk of false positives)&#xD;
&#xD;
          3. Age ≥ 18 years&#xD;
&#xD;
          4. WHO ≤ 1&#xD;
&#xD;
          5. Well-informed written consent signed by the patient and collected before any specific&#xD;
             procedure in the study&#xD;
&#xD;
          6. Patient member in a national insurance scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with a bronchial carcinoid or bronchoalveolar cancer&#xD;
&#xD;
          2. Patient with acute bronchopneumopathy&#xD;
&#xD;
          3. Not stabilized diabetic patient&#xD;
&#xD;
          4. Patient with an absolute indication against spirometry: ongoing pneumothorax or within&#xD;
             the previous month, pleural biopsy or puncture within the previous month, hemoptysis,&#xD;
             severe asthma, tuberculosis&#xD;
&#xD;
          5. Any usual relative indication against spirometry: ongoing bronchial infections, acute&#xD;
             asthma, decompensation of chronic respiratory failure, respiratory pain&#xD;
&#xD;
          6. Any usual formal indication against imaging examination PET/CT (important&#xD;
             claustrophobia)&#xD;
&#xD;
          7. Patient unable to follow study procedures&#xD;
&#xD;
          8. Pregnant women or nursing mothers can not participate in the study&#xD;
&#xD;
          9. Men and women of childbearing age must use effective contraception at study entry and&#xD;
             throughout the study&#xD;
&#xD;
         10. Any other medical conditions making the inclusion of the patient in the study&#xD;
             inappropriate in the opinion of the investigator&#xD;
&#xD;
         11. Patient under legal guardianship&#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>Frederic COURBON, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Claudius Regaud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Claudius REGAUD</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung Cancer</keyword>
  <keyword>PET/CT</keyword>
  <keyword>FDG</keyword>
  <keyword>Respiratory synchronization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720186
org study id: 12POUM01
nct id: NCT01720186
lead sponsor: 
has dmc: No
This is a pilot study, single-center, prospective, open-label, to assess the acceptability
      and performance of the experimental medical device (SPI) used during an imaging examination
      (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its
      own control, since the imaging examination will be synchronized simultaneously with the two
      systems: tested Medical Device (SPI) and reference Medical Device(RPM).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
time frame: 2 years
description: feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment):
Tolerance / acceptability of the patient to breathe into SPI throughout the examination)
Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100).
Accuracy of detection of inspiratory peak amplitudes with SPI medical device: by measuring dtSpi (dtSpi = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle).
Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device"
measure: Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
time frame: 2 years
measure: Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
time frame: 2 years
description: dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle
measure: Measure of BTVrpm (= biologic tumoral volume)
time frame: 2 years
arm group label: SPI Medical device
arm group type: Experimental
description: SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax.
arm group label: reference medical device : RPM
arm group type: Active Comparator
description: Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax.
intervention type: Device
intervention name: PET/CT 4D imaging in a synchronized mode centered on the thorax.
arm group label: SPI Medical device
arm group label: reference medical device : RPM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederic COURBON, PhD
role: Principal Investigator
affiliation: Institut Claudius Regaud
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms