Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Without the Help of an AI/ML Tech-based SaMD
This is a two arm, randomized, controlled, blinded, multi-case multi reader (MRMC), retrospective study for the evaluation of the efficacy and safety of an AI/ML technology-based CADe/x developed to detect, localize and characterize malignancy score of pulmonary nodules on LDCT chest scans taken as part of a lung cancer screening program. LDCT DICOM images of patients who underwent routine lung cancer screening will be selected and enrolled into the study. Enrolled scans analyzed by radiologists with the assistance of the Median LCS (formerly iBiopsy) device are compared to the analysis by radiologists without the assistance of the Median LCS device. Figures of merit for patient level and lesion level detection and diagnostic efficacy will be calculated and compared, sub-class analysis will be performed to ensure device generalizability.
Checked against the public recordLast updated May 6, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Median Technologies
- Interventions being studied
- Device: Median LCS
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * ≥50-80 Years of age; * Current or ex-smoker (\>=20 pack years); * Patient screened and surveilled for lung cancer screening following lung cancer screening guidelines (equivalent to United States Preventive Services Task Force (USPSTF) 2021 Criteria); * Received LDCT due to inclusion in high-risk category for lung cancer. Exclusion Criteria: * Prior lung resection; * Pacemaker or other indwelling metallic medical devices in the thorax that interfere with CT acquisition; * Patients/images used during AI model development; * Patients with only hilar and/or mediastinal cancer(s); * Patients with only ground glass cancer(s); * Patients with nodules, solid or part-solid \>30mm (masses); * Patients that are not accompanied with the required clinical information; * Patients with imaging with any of the following: missing slices, slice thickness \>3mm; * Partial cover of the lung.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Pennsylvania - Penn Center for InnovationPhiladelphia, Pennsylvania
- Baptist Clinical Research InstituteMemphis, Tennessee
- The University of Texas M.D. Anderson Cancer CenterHouston, Texas
- Fundacion instituto de investigacion sanitaria de la fundacion jimenez diaz (FJD)Madrid
- Universidad de NavarraPamplona
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 6, 2025. Always confirm current availability with the study team.