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

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Radiation: Chest X-ray

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.

• Study Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Secondary hospital patient

Description

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
• Chest radiographs from dual-energy radiography
• Invert-grayscale chest radiographs

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effectiveness of the investigational device	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)	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Lunit Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: LUN_CXR_CA_221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No