AI detection of vertebral fractures on routine chest‑abdomen CT for men over 50

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This monocentric prospective observational project will apply automatic 3D reconstruction and the NanoxAIHealthVCF (NANO‑X IMAGING LTD) software to chest‑abdomen CT scans to identify vertebral fractures. About 250 male patients aged 50 and over undergoing CT for indications unrelated to osteometabolic disease will be enrolled retrospectively and prospectively between March 1, 2025 and February 28, 2026. Radiological assessment with 3D reconstructions will be compared with the AI outputs while clinical, anthropometric, and anamnestic data are collected on the day of the CT. There is a single study evaluation at the time of the CT, and patients with detected fractures will be referred to the Endocrinology Unit per standard of care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male subjects
2. Age ≥ 50 years
3. Clinical and medical history data available at abdomen-chest CT evaluation
4. Signature of informed consent to the study

Exclusion Criteria:

1. Hospitalized patients
2. Patients known to have osteo-metabolic diseases.
3. with primary and/or acquired immunodeficiency states, and/or severe impairment of general clinical condition (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacute/compensated chronic diseases; moderate-severe renal failure)
4. Patients unable to understand and sign the Informed Consent.

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Italy, Italy Recruiting

Study contacts

• Principal investigator: Andrea Giustina, MD — IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University
• Study coordinator: Luigi Di Filippo, MD
• Email: difilippo.luigi@hsr.it
• Phone: 0226435062

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.