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

Lunit

Status: Completed

Conditions: Pulmonary Disease

Treatments: Radiation: X-ray

Study type: Observational

Funder types: Industry

Identifiers

NCT05619029

LUN_CXR_CA_222

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,111 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,111 participants in 2 patient groups

Positive

Description:

chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax)

Treatment:

Radiation: X-ray

Negative

Description:

chest radiographs with no target radiologic findings

Treatment:

Radiation: X-ray