Status:
COMPLETED
Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)
Lead Sponsor:
Median Technologies
Conditions:
High Risk Cancer
Eligibility:
All Genders
50-80 years
Brief 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 Co...
Eligibility Criteria
Inclusion
- ≥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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
1147 Patients enrolled
Trial Details
Trial ID
NCT06576232
Start Date
September 21 2022
End Date
August 21 2024
Last Update
August 28 2024
Active Locations (5)
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1
University of Pennsylvania - Penn Center for Innovation
Philadelphia, Pennsylvania, United States, 19104
2
Baptist Clinical Research Institute
Memphis, Tennessee, United States, 38120
3
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
4
Fundacion instituto de investigacion sanitaria de la fundacion jimenez diaz (FJD)
Madrid, Spain, 28040