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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05619029

Enrollment

1111

Registered

2022-11-16

Start date

2021-06-02

Completion date

2021-09-15

Last updated

2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease

Brief summary

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

Detailed description

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.

Interventions

RADIATIONX-ray

Chest radiographs

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026