NCT07052773Completed
Clinical Evaluation of the Lung Cancer AI-based Decision Support Tool in Low-Dose Lung CT
Blinded Retrospective Study to Clinically Validate the Accuracy of the Lung Cancer Detection System (LCDS) AI-based Decision Support Tool for Lung Cancer Low-Dose CT
Source: ClinicalTrials.gov · Last updated 7 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 22 Jun 2025
- Start date
- 26 Oct 2023
- Primary completion date
- 5 May 2024
- Lead sponsor
- Genesis Medical AI
- Diseases
- Lung cancer
- NCT number
- NCT07052773
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 26 Oct 2023 to the primary completion date, 5 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assuta Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.