Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on X-ray

This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities.

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

About this study

In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.

In addition, to investigate the effect of Lunit INSIGHT CXR assistance on the interpreting physician's interpreting performance, a multi-reader, multi-case (MRMC) study was conducted.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chest radiographs of aged 14 years or older
Conventional PA or AP chest radiographs
Chest radiographs with confirmed radiology reports

Exclusion criteria

Chest radiographs taken in postures other than PA and AP e.g.) decubitus, oblique, lordotic, or lateral view
Invert-grayscale chest radiographs
Image quality not suitable for interpretation due to incorrect patient positioning, inadequate image collimation, severely damaged lung presence of external materials such as jewelry

Treatment and study plan

X-Ray

Radiation

Chest radiographs

Primary outcomes

Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings

Time frame: Through study completion, an average of 6 months

To evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities, Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings (detection of any abnormal findings among ten target radiologic findings) will be measured

Sponsors and collaborators

Lead sponsor

Lunit Inc.

Industry

Registry information

Official study title

Retrospective, Observer-blinded, Pivotal Study to Evaluate the Effectiveness of the Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Nov 16, 2022
Registry last updated: Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed