Actively Recruiting
A Prospective Observational Study Using AI and 3D Imaging to Evaluate Vertebral Fractures in Men Aged 50 and Older
Led by IRCCS San Raffaele · Updated on 2026-04-08
250
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a monocentric observational prospective study to assess how common vertebral fractures are among male patients aged 50 years and older who undergo chest-abdomen CT scans for reasons other than bone metabolic diseases. The study aims to use advanced imaging techniques combined with artificial intelligence to identify fractures that may otherwise be unnoticed. Participants will have their CT scans evaluated both by radiologists using automatic 3D reconstruction of the thoracic and lumbar spine and by AI software called NanoxAIHealthVCF from NANO-X IMAGING LTD. The study plans to enroll about 250 patients between March 1, 2025, and February 28, 2026. If one or more vertebral fractures are detected by either method, the patient will be referred for further evaluation in an Endocrinology Unit as part of standard care. Participants will provide clinical, body measurement, and medical history data at the time of their CT scan. The study involves only one evaluation during the CT scan visit, with no additional study visits unless a fracture is found. The main outcome measured is the number of vertebral fractures detected by the combined AI and 3D reconstruction method during the specified enrollment period. The study is observational, so no experimental treatment is given, and patient care follows usual medical practices.
CONDITIONS
Brief Title
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects
- Age 50 years or older
- Clinical and medical history data available at abdomen-chest CT evaluation
- Signed informed consent to participate in the study
You will not qualify if you...
- Hospitalized patients
- Patients known to have osteo-metabolic diseases
- Patients with immunodeficiency or severe general health problems (such as metastatic cancer, immunosuppressive treatments, worsening chronic diseases, or moderate to severe kidney failure)
- Patients unable to understand or sign informed consent forms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 day
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit (in-person)
Duration - 1 day
Participants undergo a single abdomen-chest CT scan with radiological medical evaluation using automatic 3D reconstruction and AI software to detect vertebral fractures.
1 visit (in-person)
Duration - Variable depending on clinical care
Participants with detected vertebral fractures may be evaluated in the Endocrinology Unit as part of their standard care following the diagnostic evaluation.
Additional visits as per standard of care if fractures are detected
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
L
Luigi Di Filippo, MD
G
Gabriela Felipe, CRN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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