NCT06576232Completed
Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)
Multinational, Multicenter, Retrospective Study to Evaluate an AI/ML Technology-Based End-to-End CADe/CADx SaMD, Which Allows Detection, Localization and Characterization of Pulmonary Nodules (REALITY)
Source: ClinicalTrials.gov · Last updated 28 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1147 (actual)
- First submitted
- 23 Aug 2024
- Start date
- 21 Sept 2022
- Primary completion date
- 24 Jul 2024
- Lead sponsor
- Median Technologies
- NCT number
- NCT06576232
What you commit to
- Study type: Observational
- Participants enrolled: 1147
- From 21 Sept 2022 to the primary completion date, 24 Jul 2024
- 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.