RadiologyCORDANCT04419545
Covid Radiographic Images Data-set for A.I
An observational study of Radiology and Artificial Intelligence, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
The possibility to use widespread and simple chest X-ray (CXR) imaging for early screening of COVID-19 patients is attracting much interest from both the clinical and the Artificial intelligence community. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiology, Artificial Intelligence
- What is being tested?
- Neural network diagnosis algorithm
- How many people
- 2,500 participants
- Where
- 1 siteItaly
- Study dates
- 24 Mar 2020to 31 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the people treated in radiology dept
Who may be able to join
None listed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Città della Salute e della Scienza
Torino, Turin, 10126
Marco Grosso, M.Sc., 00390116331330, mgrosso2@gmail.com
Giorgio Limerutti, M.D.
About this study
The possibility to use widespread and simple chest X-ray (CXR) imaging for early screening of COVID-19 patients is attracting much interest from both the clinical and the Artificial intelligence community. In this study we provide insights and also raise warnings on what is reasonable to expect by applying deep learning to COVID classification of CXR images. We provide a methodological guide and critical reading of an extensive set of statistical results that can be obtained using currently available datasets. In particular, we take the challenge posed by current small size COVID data and show how significant can be the bias introduced by transfer-learning using larger public non- COVID CXR datasets. We also contribute by providing results on a medium size COVID CXR dataset, just collected by one of the major emergency hospitals in Northern Italy during the peak of the COVID pandemic. These novel data allow us to contribute to validate the generalization capacity of preliminary results circulating in the scientific community. Our conclusions shed some light into the possibility to effectively discriminate COVID using CXR.
Read the detailed description
COVID-19 virus has rapidly spread in mainland China and into multiple countries worldwide. As of April 7th 2020 in Italy, one of the most severely affected countries, 135,586 Patients with COVID19 were recorded, and 17,127 of them died; at the time of writing Piedmont is the 3rd most affected region in Italy, with 13,343 recorded cases. Early diagnosis is a key element for proper treatment of the patients and prevention of the spread of the disease. Given the high tropism of COVID-19 for respiratory airways and lung epithelium, identification of lung involvement in infected patients can be relevant for treatment and monitoring of the disease. Virus testing is currently considered the only specific method of diagnosis. The Center for Disease Control (CDC) in the US recommends collecting and testing specimens from the upper respiratory tract (nasopharyngeal and oropharyngeal swabs) or from the lower respiratory tract when available (bronchoalveolar lavage, BAL) for viral testing with reverse transcription polymerase chain reaction (RT-PCR) assay. Current position papers from radiological societies (Fleischner Society, SIRM, RSNA) do not recommend routine use of imaging for COVID-19 diagnosis.
However, it has been widely demonstrated that, even at early stages of the disease, chest x-rays (CXR) and computed tomography (CT) scans can show pathological findings. It should be noted that they are actually non specific, and overlap with other viral infections (such as influenza, H1N1, SARS and MERS): most authors report peripheral bilateral ill-defined and ground-glass opacities, mainly involving the lower lobes, progressively increasing in extension as disease becomes more severe and leading to diffuse parenchymal consolidation, CT is a sensitive tool for early detection of peripheral ground glass opacities; however routine role of CT imaging in these Patients is logistically challenging in terms of safety for health professionals and other patients, and can overwhelm available resources. Chest X-ray can be a useful tool, especially in emergency settings: it can help exclude other possible lung "noxa", allow a first rough valuation of the extent of lung involvement and most importantly can be obtained at patients bed using portable devices, limiting possible exposure in health care workers and other patients. Furthermore, CXR can be repeated over time to monitor the evolution of lung disease.
Methodology:
we describe the deeplearning approach based on quite standard pipeline, namely chest image pre-processing and lung segmentation followed by classification model obtained with transfer learning. As we will see in this section, data pre-processing is fundamental to remove any bias present in the data. In particular, we will show that it is easy for a deep model to recognize these biases which drive the learning process. Given the small size of COVID datasets, a key role is played by the larger datasets used for pre-training. Therefore, we first discuss which datasets can be used for our goals.
- Conditions
- Radiology, Artificial Intelligence
- Being tested
- Neural network diagnosis algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural network diagnosis algorithmDiagnostic test
we feed neural network with chest x-ray radiography images for teaching the network for automatic diagnosis of interstitial pneumonia
| Study group | Role | What they receive |
|---|---|---|
| interstitial pneumonia cases | Chest x-ray diagnosis Receives: Diagnostic Test: Neural network diagnosis algorithm | |
| Negative controls | Chest x-ray Negative for pneumonia Receives: Diagnostic Test: Neural network diagnosis algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensibility and specificity of neural network diagnosis
sensibility and specificity of neural network diagnosis compared with human diagnosis
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start24 Mar 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiologyStudies 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
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy, Azienda Ospedaliera Ordine Mauriziano di Torino
- Responsible party
- Principal investigator, Giorgio Limerutti, A.O.U. Città della Salute e della Scienza
- Investigators
- Giorgio Limerutti, M.D., Principal investigator, Radiology Unit A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419545
- Sponsor's protocol ID
- CORDA
- Acronym
- CORDA
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid Radiographic Images Data-set for A.I
- ClinicalTrials.gov ID
- NCT04419545
- Acronym / sponsor ID
- CORDA / CORDA
- Conditions
- Radiology, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- University of Turin, Italy, Azienda Ospedaliera Ordine Mauriziano di Torino
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 5 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.
The possibility to use widespread and simple chest X-ray (CXR) imaging for early screening of COVID-19 patients is attracting much interest from both the clinical and the Artificial intelligence community. In this study we provide insights and also raise warnings on what is reasonable to expect by applying deep learning to COVID classification of CXR images. We provide a methodological guide and critical reading of an extensive set of statistical results that can be obtained using currently available datasets. In particular, we take the challenge posed by current small size COVID data and show how significant can be the bias introduced by transfer-learning using larger public non- COVID CXR datasets. We also contribute by providing results on a medium size COVID CXR dataset, just collected by one of the major emergency hospitals in Northern Italy during the peak of the COVID pandemic. These novel data allow us to contribute to validate the generalization capacity of preliminary results circulating in the scientific community. Our conclusions shed some light into the possibility to effectively discriminate COVID using CXR.
Detailed description
COVID-19 virus has rapidly spread in mainland China and into multiple countries worldwide. As of April 7th 2020 in Italy, one of the most severely affected countries, 135,586 Patients with COVID19 were recorded, and 17,127 of them died; at the time of writing Piedmont is the 3rd most affected region in Italy, with 13,343 recorded cases. Early diagnosis is a key element for proper treatment of the patients and prevention of the spread of the disease. Given the high tropism of COVID-19 for respiratory airways and lung epithelium, identification of lung involvement in infected patients can be relevant for treatment and monitoring of the disease. Virus testing is currently considered the only specific method of diagnosis. The Center for Disease Control (CDC) in the US recommends collecting and testing specimens from the upper respiratory tract (nasopharyngeal and oropharyngeal swabs) or from the lower respiratory tract when available (bronchoalveolar lavage, BAL) for viral testing with reverse transcription polymerase chain reaction (RT-PCR) assay. Current position papers from radiological societies (Fleischner Society, SIRM, RSNA) do not recommend routine use of imaging for COVID-19 diagnosis.
However, it has been widely demonstrated that, even at early stages of the disease, chest x-rays (CXR) and computed tomography (CT) scans can show pathological findings. It should be noted that they are actually non specific, and overlap with other viral infections (such as influenza, H1N1, SARS and MERS): most authors report peripheral bilateral ill-defined and ground-glass opacities, mainly involving the lower lobes, progressively increasing in extension as disease becomes more severe and leading to diffuse parenchymal consolidation, CT is a sensitive tool for early detection of peripheral ground glass opacities; however routine role of CT imaging in these Patients is logistically challenging in terms of safety for health professionals and other patients, and can overwhelm available resources. Chest X-ray can be a useful tool, especially in emergency settings: it can help exclude other possible lung "noxa", allow a first rough valuation of the extent of lung involvement and most importantly can be obtained at patients bed using portable devices, limiting possible exposure in health care workers and other patients. Furthermore, CXR can be repeated over time to monitor the evolution of lung disease.
Methodology:
we describe the deeplearning approach based on quite standard pipeline, namely chest image pre-processing and lung segmentation followed by classification model obtained with transfer learning. As we will see in this section, data pre-processing is fundamental to remove any bias present in the data. In particular, we will show that it is easy for a deep model to recognize these biases which drive the learning process. Given the small size of COVID datasets, a key role is played by the larger datasets used for pre-training. Therefore, we first discuss which datasets can be used for our goals.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interstitial pneumonia cases | – | Diagnostic Test: Neural network diagnosis algorithmChest x-ray diagnosis |
| Negative controls | – | Diagnostic Test: Neural network diagnosis algorithmChest x-ray Negative for pneumonia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the people treated in radiology dept
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Neural network diagnosis algorithmwe feed neural network with chest x-ray radiography images for teaching the network for automatic diagnosis of interstitial pneumonia | Diagnostic test | Negative controls, interstitial pneumonia cases |
Primary outcome
sensibility and specificity of neural network diagnosis
Time frame: at day 0
sensibility and specificity of neural network diagnosis compared with human diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- 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.
Giorgio Limerutti, M.D. principal investigator
Radiology Unit A.O.U. Città della Salute e della Scienza
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 Radiology and Artificial Intelligence, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jun 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Grosso, M.Sc. (00390116331330, mgrosso2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensibility and specificity of neural network diagnosis (time frame: at day 0). 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 5 Jun 2020.