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

NCT05619029 | Completed

• 1 other identifier: LUN_CXR_CA_222
• Study Type: observational
• Target: 1,111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of 6 months

Study Arms (2)

Positive

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

Radiation: X-ray

Negative

chest radiographs with no target radiologic findings

Radiation: X-ray

Interventions

X-ray RADIATION

Chest radiographs

Negative; Positive

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The secondary hospital patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lunit Inc.: lead

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 16, 2022
• Study Start: June 2, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)