Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04561024
• Other study ID #: EN-092020
• Status: Active, not recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Ensemble Group Holdings, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Pneumonia

Intervention

Diagnostic Test:
• AI model
Deep Learning CNN model

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Ensemble Group Holdings, LLC

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Performance of AI model	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