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

NCT06576232 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1147

Last updated 2024-08-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Median Technologies

    lead INDUSTRY

Principal Investigators

  • Anil VACHANI, MD · University of Pennsylvania

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-07-24
Completion
2024-08-21
FDA Device
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576232 on ClinicalTrials.gov