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

Sponsor

Lunit Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05619029

Collaborator

(none)

1,111

Enrollment

Location

3.4

Actual Duration (Months)

322.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease	Radiation: 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.

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 Design

Study Type:

Observational

Actual Enrollment :

1111 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 2, 2021

Actual Primary Completion Date :

Sep 15, 2021

Actual Study Completion Date :

Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 Chest radiographs
Negative chest radiographs with no target radiologic findings	Radiation: X-ray Chest radiographs

Arm

Intervention/Treatment

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

Chest radiographs

Negative

chest radiographs with no target radiologic findings

Radiation: X-ray

Chest radiographs

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of	07061

Sponsors and Collaborators

Lunit Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lunit Inc.

ClinicalTrials.gov Identifier:

NCT05619029

Other Study ID Numbers:

LUN_CXR_CA_222

First Posted:

Nov 16, 2022

Last Update Posted:

Nov 16, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Study Results

No Results Posted as of Nov 16, 2022