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

N/ACompletedNCT05619029

Lunit Inc.1,111 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,111

Conditions

Pulmonary Disease

Interventions

X-rayRADIATION

Chest radiographs

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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

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

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

Data from ClinicalTrials.gov

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