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

Completed

• Conditions: Pulmonary Disease
• Interventions: Radiation: X-ray

• Registration Number: NCT05619029
• Lead Sponsor: Lunit Inc.

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.

Study Timeline

• Study Start: 2021-06-02
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-15
• Last Update Submitted: 2022-11-15
• Study First Posted: 2022-11-16
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative	X-ray	chest radiographs with no target radiologic findings
Positive	X-ray	chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of