NCT06751576

Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Without the Help of an AI/ML Tech-based SaMD

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy Of Readers Assisted By an AI/ML Technology-Based End-To-End CADe/CADx SaMD Versus Alone in the Detection, Localization and Characterization of Pulmonary Nodules in Populations With High Risk of Lung Cancer (RELIVE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 480 (actual)
• Sponsor: Median Technologies · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• High Risk Cancer
• Lung 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: 2025-01-31
• Completion: 2025-03-12
• First posted: 2024-12-30
• Last updated: 2025-05-06

Locations

5 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study