<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/NCT04424355</url>
  </required_header>
  <id_info>
    <org_study_id>2020-2</org_study_id>
    <nct_id>NCT04424355</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging to Detect Signs of Viral Pneumonia in Patients With Coronavirus Infection.</brief_title>
  <official_title>Possibilities of Chest Magnetic Resonance Imaging (MRI) in Diagnostics of COVID-19. The Use of MRI to Assess Lung Damage in Patients With Coronavirus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</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>
      Since the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in&#xD;
      detecting signs of viral pneumonia has become clear from the literature. However, the&#xD;
      increased patient flow creates an additional pressure on CT centers. We believe, the use of&#xD;
      chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is&#xD;
      not available. Lung MRI may be useful in routing a patient in a difficult epidemiological&#xD;
      situation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, with increased load of CT studies, alternative methods of viral pneumonia signs'&#xD;
      visualization are required.&#xD;
&#xD;
      Investigators hypothesize that chest MRI could be a test for detecting pulmonary features of&#xD;
      COVID-19. They consider using MRI to assess COVID-19 viral pneumonia. Absence of radiation&#xD;
      exposure to patients is a clear advantage of MRI.&#xD;
&#xD;
      This is a prospective, observational cohort study assessing patients with suspected COVID-19.&#xD;
      It's primary goal is to determine the ability of multiparametric MRI to detect lung&#xD;
      abnormalities - ground-glass opacity (GGO), consolidation, &quot;crazy paving&quot; pattern, pleuritis&#xD;
      - in comparison to CT scan. In this study each patient with suspected pneumonia will&#xD;
      sequentially undergo both chest CT and MRI during his/her visit. Scan protocols will be&#xD;
      identical for each patient. Each participants completed an online questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2020</start_date>
  <completion_date type="Actual">December 20, 2021</completion_date>
  <primary_completion_date type="Actual">July 19, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of zones of pulmonary parenchyma corresponding to viral pneumonia detected by chest MRI in comparison with CT scan</measure>
    <time_frame>Upon completion, up to 1 year</time_frame>
    <description>Expected number - more than two zones</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Coronavirus Infections</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Patients with suspected pneumonia COVID-19</arm_group_label>
    <description>Chest MRI findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, &quot;crazy paving&quot; pattern, pleuritis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with suspected pneumonia with COVID -19</arm_group_label>
    <description>Chest CT findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, &quot;crazy paving&quot; pattern, pleuritis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Chest MRI</intervention_name>
    <description>Patients referred by the primary care physician with suspected pneumonia</description>
    <arm_group_label>Patients with suspected pneumonia with COVID -19</arm_group_label>
    <other_name>Chest CT scan</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with suspected viral COVID-19 pneumonia will be included in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A referral from the attending physician for a chest CT scan&#xD;
&#xD;
          -  Suspected pneumonia&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Presence of foreign implanted objects in the body at the scan level (including cardiac&#xD;
             pacemakers, spine metalware)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</name>
      <address>
        <city>Moscow</city>
        <zip>109029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department</investigator_affiliation>
    <investigator_full_name>Sergey Morozov</investigator_full_name>
    <investigator_title>Chief Research Officer</investigator_title>
  </responsible_party>
  <keyword>Computed tomography</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>Lung MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_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/NCT04424355
org study id: 2020-2
nct id: NCT04424355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in
      detecting signs of viral pneumonia has become clear from the literature. However, the
      increased patient flow creates an additional pressure on CT centers. We believe, the use of
      chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is
      not available. Lung MRI may be useful in routing a patient in a difficult epidemiological
      situation.
Currently, with increased load of CT studies, alternative methods of viral pneumonia signs'
      visualization are required.

      Investigators hypothesize that chest MRI could be a test for detecting pulmonary features of
      COVID-19. They consider using MRI to assess COVID-19 viral pneumonia. Absence of radiation
      exposure to patients is a clear advantage of MRI.

      This is a prospective, observational cohort study assessing patients with suspected COVID-19.
      It's primary goal is to determine the ability of multiparametric MRI to detect lung
      abnormalities - ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis
      - in comparison to CT scan. In this study each patient with suspected pneumonia will
      sequentially undergo both chest CT and MRI during his/her visit. Scan protocols will be
      identical for each patient. Each participants completed an online questionnaire.
observational model: Case-Control
time perspective: Prospective
measure: Number of zones of pulmonary parenchyma corresponding to viral pneumonia detected by chest MRI in comparison with CT scan
time frame: Upon completion, up to 1 year
description: Expected number - more than two zones
arm group label: Patients with suspected pneumonia COVID-19
description: Chest MRI findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis.
arm group label: Patients with suspected pneumonia with COVID -19
description: Chest CT findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis.
intervention type: Diagnostic Test
intervention name: Chest MRI
description: Patients referred by the primary care physician with suspected pneumonia
arm group label: Patients with suspected pneumonia with COVID -19
other name: Chest CT scan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
investigator full name: Sergey Morozov
investigator title: Chief Research Officer
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pneumonia
mesh term: Coronavirus Infections
sharing ipd: No