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

NCT06751576 | Completed FDA Device

• 1 other identifier: MT-LCS-004
• Study Type: observational
• Target: 480
• Locations: 2 countries
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• ∆ AUC of ROCs > 0. Delta Area between the Response operating curve (AUROC) value with Median LCS and AUROC without Median LCS at patient level data is superior to 0.

  Demonstrate that patient diagnosis with Median LCS is improved compared to without Median LCS.

  12 months

Secondary Outcomes (6)

• Sensitivity at max Youden

  12 months

• Specificity at max Youden

  12 months

• ∆ AUC of LROC > 0

  12 months

• Recall rates for non-cancer patients (Specificity)

  12 months

• Recall rates for cancer patients (Sensitivity)

  12 months

Study Arms (2)

Control arm

low-dose CT scan image readings performed by radiologists without the assistance of Median LCS

Test arm

low-dose CT scan image readings performed by radiologists with the assistance of Median LCS.

Device: Median LCS

Interventions

Median LCS DEVICE

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.

Also known as: eyonis LCS

Test arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High risk lung cancer population from Radiology or Pneumology hospital departments. Patients enrolled in this study were retrospectively collected from centers across the EU and USA where they were enlisted into lung cancer screening due to high risk of lung cancer according to established lung cancer screening guidelines. The cohort used for testing the efficacy and safety of the device will be an "enriched cohort" with a 1:2 distribution of cancer positive and benign patients

You may qualify if:

• ≥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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Median Technologies: lead

Study Sites (5)

University of Pennsylvania - Penn Center for Innovation

Philadelphia, Pennsylvania, 19104, United States

Location

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fundacion instituto de investigacion sanitaria de la fundacion jimenez diaz (FJD)

Madrid, 28040, Spain

Location

Universidad de Navarra

Pamplona, 31009, Spain

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anil VACHANI, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: September 21, 2022
• Primary Completion: January 31, 2025
• Study Completion: March 12, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (3); ES (2)