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Magnetic Resonance Imaging to Detect Signs of Viral Pneumonia in Patients With Coronavirus Infection.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424355
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Coronavirus Infections Pneumonia Diagnostic Test: Chest MRI

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : May 19, 2020
Estimated Primary Completion Date : July 19, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with suspected pneumonia COVID-19
Chest MRI findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis.
 Diagnostic Test: Chest MRI
Patients referred by the primary care physician with suspected pneumonia
Other Name: Chest CT scan
Patients with suspected pneumonia with COVID -19
Chest CT findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis.
 Diagnostic Test: Chest MRI
Patients referred by the primary care physician with suspected pneumonia
Other Name: Chest CT scan


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Expected number - more than two zones


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with suspected viral COVID-19 pneumonia will be included in the study
Criteria

Inclusion Criteria:

  • A referral from the attending physician for a chest CT scan
  • Suspected pneumonia
  • Signed informed consent
  • Over 18 years old

Exclusion Criteria:

  • Pregnant or nursing women
  • Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424355


Contacts
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Contact: Olga Panina +79266210179 olgayurpanina@gmail.com
Contact: Yuri Vasilev +79067716776 dr.vasilev@me.com

Locations
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Russian Federation
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department Recruiting
Moscow, Russian Federation, 109029
Contact: Olga Panina    +79266210179    olgayurpanina@gmail.com   
Sponsors and Collaborators
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
More Information
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Publications:

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Responsible Party: Sergey Morozov, Chief Research Officer, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
ClinicalTrials.gov Identifier: NCT04424355    
Other Study ID Numbers: 2020-2
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department:
Computed tomography
Magnetic resonance imaging
Lung MRI
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases