Coronavirus InfectionsNCT04424355
Magnetic Resonance Imaging to Detect Signs of Viral Pneumonia in Patients With Coronavirus Infection.
An observational study of Coronavirus Infections and Pneumonia, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections, Pneumonia
- What is being tested?
- Chest MRI
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- 19 May 2020to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with suspected viral COVID-19 pneumonia will be included in the study
Who may be able to join
- A referral from the attending physician for a chest CT scan
- Suspected pneumonia
- Signed informed consent
- Over 18 years old
Who cannot join
- Pregnant or nursing women
- Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Moscow, 109029
About this study
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
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.
Read the 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.
- Conditions
- Coronavirus Infections, Pneumonia
- Being tested
- Chest MRI
- Keywords
- Computed tomography, Magnetic resonance imaging, Lung MRI
- Medical subject headings
- Coronavirus Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest MRIDiagnostic test
Also called Chest CT scan
Patients referred by the primary care physician with suspected pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected pneumonia COVID-19 | Chest MRI findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis. | |
| Patients with suspected pneumonia with COVID -19 | Chest CT findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis. Receives: Diagnostic Test: Chest MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of zones of pulmonary parenchyma corresponding to viral pneumonia detected by chest MRI in comparison with CT scan
Expected number - more than two zones
Measured: Upon completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start19 May 2020
- Primary completion19 Jul 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424355
- Sponsor's protocol ID
- 2020-2
- Status last verified
- Mar 2023
- First submitted
- 5 Jun 2020
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04424355
- Acronym / sponsor ID
- 2020-2
- Conditions
- Coronavirus Infections, Pneumonia
- Keywords
- Computed tomography, Magnetic resonance imaging, Lung MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care DepartmentUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected pneumonia COVID-19 | – | –Chest MRI findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis. |
| Patients with suspected pneumonia with COVID -19 | – | Diagnostic Test: Chest MRIChest CT findings: bilateral, diffuse ground-glass opacity (GGO), consolidation, "crazy paving" pattern, pleuritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected viral COVID-19 pneumonia will be included in the study
Key inclusion criteria (4 listed)
- A referral from the attending physician for a chest CT scan
- Suspected pneumonia
- Signed informed consent
- Over 18 years old
Key exclusion criteria (2 listed)
- Pregnant or nursing women
- Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest MRIAlso: Chest CT scanPatients referred by the primary care physician with suspected pneumonia | Diagnostic test | Patients with suspected pneumonia with COVID -19 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections and Pneumonia, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.