NCT06751576Completed
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)
Source: ClinicalTrials.gov · Last updated 6 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 480 (actual)
- First submitted
- 20 Dec 2024
- Start date
- 21 Sept 2022
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Median Technologies
- Diseases
- Lung cancer
- NCT number
- NCT06751576
What you commit to
- Study type: Observational
- Participants enrolled: 480
- From 21 Sept 2022 to the primary completion date, 31 Jan 2025
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior lung resection;
Other illness
- Patients with only hilar and/or mediastinal cancer(s);
- Patients with only ground glass cancer(s);
Other
- Pacemaker or other indwelling metallic medical devices in the thorax that interfere with CT acquisition;
- Patients/images used during AI model development;
- 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.
Who the study is looking for
- ≥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.
Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion instituto de investigacion sanitaria de la fundacion jimenez diaz (FJD) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Universidad de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| The University of Texas M. D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Baptist Clinical Research Institute Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| University of Pennsylvania - Penn Center for Innovation Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.