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Age: 50Years +
MALE
ID06449742

Observational Study Using AI and 3D Imaging to Detect Vertebral Fractures in Men 50 and Older Undergoing Chest-Abdomen CT Scans

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

Age: 50Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

L

Luigi Di Filippo, MD

G

Gabriela Felipe, CRN

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