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/NCT06012890</url>
    </required_header>
    <id_info>
      <org_study_id>2023-01047</org_study_id>
      <nct_id>NCT06012890</nct_id>
    </id_info>
    <brief_title>Performance of Acquisition Automation of Cardiac MRI</brief_title>
    <official_title>Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Geneva</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Geneva</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>
        For this study, cardiac MRI examinations performed will be prospectively included and&#xD;
        realized either fully automatically or by a specialized radiology technician. The duration of&#xD;
        the automated examinations will be compared to the duration of the manual examinations. The&#xD;
        number of failed sequences in both study arms (automated and manual) will be recorded and the&#xD;
        quality of the cardiac planes will be compared.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main hypothesis is that fully automated cardiac MRI protocols require shorter overall&#xD;
        scan times than manually acquired, human-executed protocols. The objective will be to&#xD;
        demonstrate that automating the examination allows to shorten the scan time, leading to&#xD;
        increased patient comfort and clinical flexibility. The study's secondary objective will be&#xD;
        to demonstrate the non-inferiority of the automated protocol compared to human acquisition in&#xD;
        terms of resulting planning quality and error occurrence during slice planning.&#xD;
  &#xD;
        Included patients will undergo clinical cMRI following international and national standards:&#xD;
        only the acquisition strategy will vary. The investigators will successively recruit patients&#xD;
        presenting for routine cardiac MRI. The acquisition strategy of the MRI - either automated or&#xD;
        manual - will alternate to avoid comparison bias.&#xD;
  &#xD;
        The MRI protocol will be the same for both arms and consists of standardized sequences&#xD;
        acquired before and after contrast administration. Recruitment will be performed at a single&#xD;
        location, in the radiology department. Patients will be recruited on a daily, consecutive&#xD;
        basis during clinical practice.&#xD;
  &#xD;
        No questionnaire will be used for this study. No biological material will be sampled.&#xD;
        Observational data about the acquisition process, potential errors, and patient&#xD;
        characteristics will be recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall scan time</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>This study's primary endpoint will be the overall scan time, from first to last MRI image acquired.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Workflow</condition>
    <condition>Time</condition>
    <arm_group>
      <arm_group_label>Automatic acquisition</arm_group_label>
      <description>Clinical MRI planning performed automatically by an AI-based software</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Manual Acquisition</arm_group_label>
      <description>Clinical MRI planning performed manually by a specialized radiology technician</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Automation of cardiac MRI acquisition</intervention_name>
      <description>The intervention will consist of the automation of the cMRI examination.</description>
      <arm_group_label>Automatic acquisition</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          General population referred for morphological cardiac MRI, with consecutive patient&#xD;
          sampling.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patient presenting for morphologic and functional assessment of the myocardium&#xD;
               by cardiac MRI.&#xD;
  &#xD;
            -  Research consent form obtained after information procedure.&#xD;
  &#xD;
            -  Complete cardiac MRI protocol performed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to provide informed consent.&#xD;
  &#xD;
            -  Implantable cardiac device&#xD;
  &#xD;
            -  Incomplete cardiac examination due to early termination by the patient.&#xD;
  &#xD;
            -  Incomplete data on examination parameters (missing forms).&#xD;
  &#xD;
            -  Incompatible MRI protocol&#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>Carl Glessgen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radiologist</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carl Glessgen, MD</last_name>
      <phone>00795536227</phone>
      <email>carl.glessgen@hcuge.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital, Geneva</name>
        <address>
          <city>Geneva</city>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
      <investigator_full_name>Carl Glessgen</investigator_full_name>
      <investigator_title>Medical Doctor, Consultant</investigator_title>
    </responsible_party>
    <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/NCT06012890
  org study id: 2023-01047
  nct id: NCT06012890
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  For this study, cardiac MRI examinations performed will be prospectively included and
        realized either fully automatically or by a specialized radiology technician. The duration of
        the automated examinations will be compared to the duration of the manual examinations. The
        number of failed sequences in both study arms (automated and manual) will be recorded and the
        quality of the cardiac planes will be compared.
  The main hypothesis is that fully automated cardiac MRI protocols require shorter overall
        scan times than manually acquired, human-executed protocols. The objective will be to
        demonstrate that automating the examination allows to shorten the scan time, leading to
        increased patient comfort and clinical flexibility. The study's secondary objective will be
        to demonstrate the non-inferiority of the automated protocol compared to human acquisition in
        terms of resulting planning quality and error occurrence during slice planning.
  
        Included patients will undergo clinical cMRI following international and national standards:
        only the acquisition strategy will vary. The investigators will successively recruit patients
        presenting for routine cardiac MRI. The acquisition strategy of the MRI - either automated or
        manual - will alternate to avoid comparison bias.
  
        The MRI protocol will be the same for both arms and consists of standardized sequences
        acquired before and after contrast administration. Recruitment will be performed at a single
        location, in the radiology department. Patients will be recruited on a daily, consecutive
        basis during clinical practice.
  
        No questionnaire will be used for this study. No biological material will be sampled.
        Observational data about the acquisition process, potential errors, and patient
        characteristics will be recorded.
  observational model: Cohort
  time perspective: Prospective
  measure: Overall scan time
  time frame: Up to 12 months
  description: This study's primary endpoint will be the overall scan time, from first to last MRI image acquired.
  arm group label: Automatic acquisition
  description: Clinical MRI planning performed automatically by an AI-based software
  arm group label: Manual Acquisition
  description: Clinical MRI planning performed manually by a specialized radiology technician
  intervention type: Other
  intervention name: Automation of cardiac MRI acquisition
  description: The intervention will consist of the automation of the cMRI examination.
  arm group label: Automatic acquisition
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Carl Glessgen, MD
  role: Principal Investigator
  affiliation: Radiologist
  last name: Carl Glessgen, MD
  phone: 00795536227
  email: carl.glessgen@hcuge.ch
  facility: 
  status: Recruiting
  country: Switzerland
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Geneva
  investigator full name: Carl Glessgen
  investigator title: Medical Doctor, Consultant
  sharing ipd: No