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Clinical Evaluation of the Lung Cancer AI-based Decision Support Tool in Low-Dose Lung CT

NCT07052773 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-07-07

No results posted yet for this study

Summary

The goal of this observational study is to clinically validate the accuracy of an AI-based decision support tool-the Lung Cancer Detection System (LCDS)-for detecting lung nodules in asymptomatic adults aged 50-79 with a history of heavy smoking who underwent low-dose chest CT (LDCT) scans.

The main questions it aims to answer are:

* Can the LCDS accurately detect the presence of solid pulmonary nodules on LDCT scans, as measured by sensitivity and specificity?
* How does the LCDS's performance compare to existing AI systems using the Area Under the Curve-Receiver Operating Characteristic (AUC/ROC) Curve?

Researchers will compare the AI-based interpretations to a ground truth established by consensus among radiologists' double-readings to see if the LCDS can accurately classify cases as 'lung nodule presence' or 'lung nodule absence'.

Participants will:

* Have their de-identified LDCT scans (collected between 2018 and 2023) reviewed retrospectively.
* Be evaluated through the LCDS tool, which will classify cases based on lung nodule presence.

Contribute to performance evaluation using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and ROC analysis.

Conditions

  • Lung Cancer Screening

Interventions

DEVICE

Lung Cancer Detection System (LCDS)

An AI-based decision support software designed to detect solid pulmonary nodules on LDCT chest scans. In this study, the LCDS is applied retrospectively to 100 previously acquired LDCT scans, and its performance is compared to a ground truth established by double-read radiologist reports with arbitration.

Sponsors & Collaborators

  • Genesis Medical AI

    lead INDUSTRY

Principal Investigators

  • Arnon Makori, MD · Assuta Medical Center

  • Shay Cohen, MBA · Genesis Medical AI

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2024-05-05
Completion
2024-05-05

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07052773 on ClinicalTrials.gov