Covid Radiographic Images Data-set for A.I

NCT ID: NCT04419545

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-24

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Radiology Artificial Intelligence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

interstitial pneumonia cases

Chest x-ray diagnosis

Neural network diagnosis algorithm

Intervention Type DIAGNOSTIC_TEST

we feed neural network with chest x-ray radiography images for teaching the network for automatic diagnosis of interstitial pneumonia

Negative controls

Chest x-ray Negative for pneumonia

Neural network diagnosis algorithm

Intervention Type DIAGNOSTIC_TEST

we feed neural network with chest x-ray radiography images for teaching the network for automatic diagnosis of interstitial pneumonia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neural network diagnosis algorithm

we feed neural network with chest x-ray radiography images for teaching the network for automatic diagnosis of interstitial pneumonia

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Turin, Italy

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Ordine Mauriziano di Torino

OTHER

Sponsor Role collaborator

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giorgio Limerutti

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giorgio Limerutti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Radiology Unit A.O.U. Città della Salute e della Scienza

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliero Universitaria Città della Salute e della Scienza

Torino, Turin, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marco Grosso, M.Sc.

Role: CONTACT

00390116331330

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marco Grosso, M.Sc.

Role: primary

00390116331330

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CORDA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparison of CXR and MnDCT
NCT00188435 COMPLETED PHASE1
Rapid Abdominal Diagnosis With AI & Radiology
NCT07040358 ACTIVE_NOT_RECRUITING