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

November 15, 2022 updated by: Lunit Inc.

Retrospective, Observer-blinded, Pivotal Study to Evaluate the Effectiveness of the 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

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

The secondary hospital patients

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings
Time Frame: 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
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lunit Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUN_CXR_CA_222

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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