- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358536
Classification of COVID-19 Infection in Posteroanterior Chest X-rays
April 21, 2020 updated by: Dascena
Classification of COVID-19 Infection in Posteroanterior Chest X-rays With Common Deep Learning Architectures
The objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images.
Study Overview
Detailed Description
The December 2019 outbreak of COVID-19 has now evolved into a public health emergency of global concern.
Given the rapid spread of infection, the rapid depletion of hospital resources due to high influxes of patients, and the current absence of specific therapeutic drugs and vaccines for treatment of COVID-19 infection, it is essential to detect onset of the disease at its early stages.
Radiological examinations, the most common of which are posteroanterior chest X-ray (PCX) images, play an important role in the diagnosis of COVID-19.
The objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images.
The primary experimental dataset consisted of 115 COVID-19 positive and 115 COVID-19 negative PCX images, the latter comprising roughly equally many pneumonia, emphysema, fibrosis, and healthy images (230 total images).
Two common convolutional neural network architectures were used, VGG16 and DenseNet121, the former initially configured with off-the-shelf (OTS) parameters and the latter with either OTS or exclusively X-ray trained (XRT) parameters.
The OTS parameters were derived from training on the ImageNet dataset, while the XRT parameters were obtained from training on the NIH chest X-ray dataset, ChestX-ray14.
A final, densely connected layer was added to each model, the parameters of which were trained and validated on 87% of images from the experimental dataset, for the task of binary classification of images as COVID-19 positive or COVID-19 negative.
Each model was tested on a hold-out set consisting of the other 13% of images.
Performance metrics were calculated as the average over five random 80%-20% splits of the images into training and validation sets, respectively.
Study Type
Observational
Enrollment (Actual)
230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Oakland, California, United States, 94612-2603
- Dascena
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
115 COVID-19 single PCX images and 115 non COVID-19 single PCX images (230 images total), collected from 81 unique COVID-19 patients and 91 unique non COVID-19 patients.
Description
Inclusion Criteria:
- Single PCX images collected from patients over 18 years of age
Exclusion Criteria:
- CT scans composed of multiple concerted X-rays
- Single PCX images collected from patients under 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COVID-19 Patients
Single posteroanterior (or "front-on") X-rays collected from COVID-19 patients
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Convolutional neural network for classification of COVID-19 from chest X-rays
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Non COVID-19 Patients
Single posteroanterior (or "front-on") X-rays collected from subsets of non COVID-19 patients
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Convolutional neural network for classification of COVID-19 from chest X-rays
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of COVID-19
Time Frame: Through study completion, an average of 2 months
|
Identification of COVID-19 infection from chest X-ray analysis
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Through study completion, an average of 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
April 17, 2020
Study Completion (Actual)
April 17, 2020
Study Registration Dates
First Submitted
April 20, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04202002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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