Clinical Evaluation of the Lung Cancer AI-based Decision Support Tool in Low-Dose Lung CT (GenMedAILCSD1)

Genesis Medical AI

Status: Completed

Conditions: Lung Cancer Screening

Treatments: Device: Lung Cancer Detection System (LCDS)

Study type: Observational

Funder types: Industry

Identifiers

NCT07052773

privately funded (Other Identifier)

0077-23-ASMC

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergone an LDCT scan between 2018 and 2023, while a diagnosis record exists.
• Age is between 50-79 years old.
• History of smoking at least a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.

Exclusion criteria

• History of lung cancer: Subjects with a previous diagnosis of lung cancer may be excluded to ensure that the study focuses on detecting new cases or evaluating the progression of the disease.
• Prior lung nodule detection: Individuals who have previously undergone LDCT scans with documented lung nodules that required medical intervention may be excluded to avoid potential confounding factors in the analysis.

Trial design

100 participants in 1 patient group

Retrospective LDCT Scan Cohort

Description:

This cohort consists of 100 de-identified low-dose CT (LDCT) chest scans collected from individuals aged 50-79 years, with a ≥20 pack-year smoking history. These scans, acquired between 2018 and 2023 during routine lung cancer screening, include cases both with and without radiologically confirmed pulmonary nodules. The scans will be retrospectively evaluated by the AI-based Lung Cancer Detection System (LCDS).

Treatment:

Device: Lung Cancer Detection System (LCDS)