Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date June 5, 2020
First Posted Date June 9, 2020
Last Update Posted Date December 10, 2020
Actual Study Start Date May 19, 2020
Estimated Primary Completion Date July 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Magnetic Resonance Imaging to Detect Signs of Viral Pneumonia in Patients With Coronavirus Infection.
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with suspected viral COVID-19 pneumonia will be included in the study
Condition
  • Coronavirus Infections
  • Pneumonia
Intervention Diagnostic Test: Chest MRI
Patients referred by the primary care physician with suspected pneumonia
Other Name: Chest CT scan
Study Groups/Cohorts
  • Patients with suspected pneumonia COVID-19
    Chest MRI findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis.
    Intervention: Diagnostic Test: Chest MRI
  • Patients with suspected pneumonia with COVID -19
    Chest CT findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis.
    Intervention: Diagnostic Test: Chest MRI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2020)
115
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2021
Estimated Primary Completion Date July 19, 2021   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Olga Panina +79266210179 olgayurpanina@gmail.com
Contact: Yuri Vasilev +79067716776 dr.vasilev@me.com
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04424355
Other Study ID Numbers 2020-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Study Sponsor Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Collaborators Not Provided
Investigators Not Provided
PRS Account Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Verification Date December 2020