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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedMedian LCS

The study team can explain what participation involves.

Who it may be forHigh Risk Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 6, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Median Technologies

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Median Technologies
Interventions being studied: Device: Median LCS

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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