<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/NCT02973373</url>
  </required_header>
  <id_info>
    <org_study_id>MR-HFV</org_study_id>
    <nct_id>NCT02973373</nct_id>
  </id_info>
  <brief_title>MRI of the Chest Under High Frequency Ventilation</brief_title>
  <official_title>MRI of the Chest Under High Frequency Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the benefit on image quality of MRI of the chest&#xD;
      performed under high frequency non-invasive ventilation. This technique indeed allows to&#xD;
      generate an apnea duration of several minutes with acquisitions performed at full&#xD;
      inspiration. This study will be applied on healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High frequency ventilation (HF-V) has been applied by using a non-invasive interface allowing&#xD;
      to obtain a prolonged apnea in awaken subjects. Such an application should be of interest for&#xD;
      MRI taking into account its susceptibility to motion of the chest and the imperfect&#xD;
      techniques of respiratory gating that are usually performed at end expiration. The purpose of&#xD;
      this study is to assess the benefit on image quality of different sequences performed with&#xD;
      and without the device in healthy subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise)</measure>
    <time_frame>within 2 weeks after MRI acquisition</time_frame>
    <description>Image quality and artefacts will be evaluated and compared without and with the device. Sharpness of the interfaces between vessels and lung will be evaluated with the Soapbubble software (Etienne et al., Magn Reson Med. 2002 Oct;48(4):658-66). The interface between diaphragm and lung will be evaluated with the maximum of the first derivative (Tibiletti et al., Magn Reson Med. 2016 Mar;75(3):1324-32). Signal to noise and contrast to noise will be measured within regions of interest in the image.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart and coronary arteries evaluation (soapbubble, signal to noise, contrast to noise)</measure>
    <time_frame>within 2 weeks after MRI acquisition</time_frame>
    <description>The potential benefit on the exploration of the heart and coronary arteries will be assessed. Sharpness of the coronary arteries with respect to the neighbouring tissue will be evaluated with the Soapbubble software (Etienne et al., Magn Reson Med. 2002 Oct;48(4):658-66). Signal to noise and contrast to noise will be measured within regions of interest in the image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synchronization of the acquisition</measure>
    <time_frame>during the MRI examination</time_frame>
    <description>The possibility of synchronizing the MRI acquisition with the ventilation system will be explored with the aim to eliminate residual diaphragmatic motion and evaluate the potential additional benefit in terms of image quality and artefacts will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective tolerance (questionnaire)</measure>
    <time_frame>at the end of the MRI examination</time_frame>
    <description>Subjective tolerance of MRI examination under HF-NIV (questionnaire). Participants will fill the questionnaire right after the examination end.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Non-invasive Ventilation</condition>
  <condition>High-frequency Ventilation</condition>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>MRI with HF-NIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Acquisition of MRI with High-Frequency non-invasive ventilation (HF-NIV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRI without HF-NIV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: MRI without High-Frequency non-invasive ventilation (HF-NIV)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI with High-frequency non-invasive ventilation</intervention_name>
    <description>MRI performed under high-frequency non-invasive ventilation</description>
    <arm_group_label>MRI with HF-NIV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI without High-frequency non-invasive ventilation</intervention_name>
    <description>MRI performed without High-frequency non-invasive ventilation</description>
    <arm_group_label>MRI without HF-NIV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjets : normal respiratory function and no known lung disease&#xD;
&#xD;
          -  Age &gt;=18y&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine I Beigelman-Aubry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Lausanne Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Delacoste J, Dournes G, Dunet V, Ogna A, Noirez L, Simons J, Long O, Berchier G, Stuber M, Lovis A, Beigelman-Aubry C. Ultrashort echo time imaging of the lungs under high-frequency noninvasive ventilation: A new approach to lung imaging. J Magn Reson Imaging. 2019 Dec;50(6):1789-1797. doi: 10.1002/jmri.26808. Epub 2019 May 28. Erratum In: J Magn Reson Imaging. 2021 Feb;53(2):642.</citation>
    <PMID>31136048</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Beigelman-Aubry Catherine</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>Chest</keyword>
  <keyword>Apnea</keyword>
  <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/NCT02973373
org study id: MR-HFV
nct id: NCT02973373
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate the benefit on image quality of MRI of the chest
      performed under high frequency non-invasive ventilation. This technique indeed allows to
      generate an apnea duration of several minutes with acquisitions performed at full
      inspiration. This study will be applied on healthy subjects.
High frequency ventilation (HF-V) has been applied by using a non-invasive interface allowing
      to obtain a prolonged apnea in awaken subjects. Such an application should be of interest for
      MRI taking into account its susceptibility to motion of the chest and the imperfect
      techniques of respiratory gating that are usually performed at end expiration. The purpose of
      this study is to assess the benefit on image quality of different sequences performed with
      and without the device in healthy subjects.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise)
time frame: within 2 weeks after MRI acquisition
description: Image quality and artefacts will be evaluated and compared without and with the device. Sharpness of the interfaces between vessels and lung will be evaluated with the Soapbubble software (Etienne et al., Magn Reson Med. 2002 Oct;48(4):658-66). The interface between diaphragm and lung will be evaluated with the maximum of the first derivative (Tibiletti et al., Magn Reson Med. 2016 Mar;75(3):1324-32). Signal to noise and contrast to noise will be measured within regions of interest in the image.
measure: Heart and coronary arteries evaluation (soapbubble, signal to noise, contrast to noise)
time frame: within 2 weeks after MRI acquisition
description: The potential benefit on the exploration of the heart and coronary arteries will be assessed. Sharpness of the coronary arteries with respect to the neighbouring tissue will be evaluated with the Soapbubble software (Etienne et al., Magn Reson Med. 2002 Oct;48(4):658-66). Signal to noise and contrast to noise will be measured within regions of interest in the image.
measure: Synchronization of the acquisition
time frame: during the MRI examination
description: The possibility of synchronizing the MRI acquisition with the ventilation system will be explored with the aim to eliminate residual diaphragmatic motion and evaluate the potential additional benefit in terms of image quality and artefacts will be evaluated.
measure: Subjective tolerance (questionnaire)
time frame: at the end of the MRI examination
description: Subjective tolerance of MRI examination under HF-NIV (questionnaire). Participants will fill the questionnaire right after the examination end.
arm group label: MRI with HF-NIV
arm group type: Experimental
description: Intervention: Acquisition of MRI with High-Frequency non-invasive ventilation (HF-NIV)
arm group label: MRI without HF-NIV
arm group type: Active Comparator
description: Intervention: MRI without High-Frequency non-invasive ventilation (HF-NIV)
intervention type: Device
intervention name: MRI with High-frequency non-invasive ventilation
description: MRI performed under high-frequency non-invasive ventilation
arm group label: MRI with HF-NIV
intervention type: Other
intervention name: MRI without High-frequency non-invasive ventilation
description: MRI performed without High-frequency non-invasive ventilation
arm group label: MRI without HF-NIV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine I Beigelman-Aubry, MD
role: Principal Investigator
affiliation: University Hospitals Lausanne Switzerland
facility: 
country: Switzerland
citation: Delacoste J, Dournes G, Dunet V, Ogna A, Noirez L, Simons J, Long O, Berchier G, Stuber M, Lovis A, Beigelman-Aubry C. Ultrashort echo time imaging of the lungs under high-frequency noninvasive ventilation: A new approach to lung imaging. J Magn Reson Imaging. 2019 Dec;50(6):1789-1797. doi: 10.1002/jmri.26808. Epub 2019 May 28. Erratum In: J Magn Reson Imaging. 2021 Feb;53(2):642.
PMID: 31136048
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Beigelman-Aubry Catherine
investigator title: MD
sharing ipd: No