NCT06576232

Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)

Multinational, Multicenter, Retrospective Study to Evaluate an AI/ML Technology-Based End-to-End CADe/CADx SaMD, Which Allows Detection, Localization and Characterization of Pulmonary Nodules (REALITY)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,147 (actual)
• Sponsor: Median Technologies · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a Multinational, Multicenter, retrospective study for the evaluation of the standalone efficacy and safety of an Artificial Intelligence/Machine Learning (AI/ML) technology-based end-to-end Computer assisted Detection/Computer Assisted Diagnosis (CADe/CADx) Software as a Medical Device (SaMD) developed to detect, localize and characterize malignant, and suspicious for lung cancer nodules on Low Dose Computed Tomography (LDCT) scans taken as part of a Lung Cancer Screening (LCS) program. LDCT Digital Imaging and Communications in Medicine (DICOM) images of patients who underwent lung cancer screening were selected and included into the study. Selected scans will then be analyzed by the CADe/CADx SaMD and compared to radiologist generated reference standards including lesions localization and lesion cancer diagnosis. Figures of merit at patient level and lesion level detection and diagnostic efficacy will be calculated as well as sub-class analysis to ensure algorithm performance generalizability.

Conditions

• High Risk Cancer

Interventions

Type	Name	Description
DEVICE	Median LCS	End-to-end processing of chest LDCT DICOM images by an AI/ML tech-based SaMD to detect, localize, and characterize (assign a malignancy score) each detected pulmonary nodule. The output of the device is a DICOM File (Median LCS result report) summarizing results per patient.

Timeline

• Start date: 2022-09-21
• Primary completion: 2024-07-24
• Completion: 2024-08-21
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

5 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study