Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm

September 22, 2020 updated by: Ensemble Group Holdings, LLC

Evaluation of a Chest X-Ray AI Neural Network (RadGen SARS-CoV2 Detection System) for the Detection of RT-PCR Confirmed SARS-Cov2 Covid-19 Pneumonia

This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is an international multi-center study. Chest radiographs (CXR) from different participating centers will be collected to develop an AI algorithm to detect COVID-19 pneumonia. This will be tested on external hold out datasets from different centers using SARS-CoV-2 by Real-Time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Assay as ground truth.

Study Type

Observational

Enrollment (Anticipated)

4000

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

There will be three subsets of study population in this study; patients who were

  1. RT-PCR confirmed COVID-19 positive
  2. RT-PCR confirmed COVID-19 negative
  3. either had a diagnosis of pneumonia before the 1st January 2020.

Description

Inclusion Criteria:

  • All adult patients >18 years of age
  • Attended any of the participating institutes between February 1, 2020 until September, 2020
  • Underwent both RT-PCR testing and frontal CXR (within 48 hours of PCR testing) for COVID-19 infection
  • frontal CXR of patients pre-covid pandemic

Exclusion Criteria:

  • Unavailability of patient demographics and clinical data
  • Inconclusive RT-PCR results
  • CXR considered to be of non-diagnostic quality by the clinical radiology research team at each site
  • CXR not in a retrievable or processable format for AI inference

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
RT-PCR Positive Patients
RT-PCR confirmed patients positive for SARS-CoV-2
Diagnostic test: AI model
Deep Learning CNN model
Negative patients
RT-PCR confirmed patients negative for SARS-CoV-2 or patients with CXR performed before the emergence of COVID-19 pandemic
Diagnostic test: AI model
Deep Learning CNN model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance of AI model
Time Frame: 9 months
Performance (accuracy, sensitivity, specificity, false-positive rate (FPR), false-negative rate (FNR), and Area Under the Curve (AUC)) of the AI model in detection of COVID-19 pneumonia on their baseline CXR using RT-PCR and historical controls as gold standard in a multi-center / multi-national cohort.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ensemble Group Holdings, LLC

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)

March 1, 2020

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN-092020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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