AI detection of vertebral fractures on routine chest‑abdomen CT for men over 50
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
This project will try AI software to find vertebral fractures on chest‑abdomen CT scans in men aged 50 and older who have CTs for reasons other than bone disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06449742 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 50 years or older who are outpatients undergoing a chest‑abdomen CT at IRCCS Ospedale San Raffaele for reasons other than known osteometabolic disease and who can give informed consent.
Not a fit: Hospitalized patients, those with known osteometabolic disease or severe comorbidities, women, or anyone unable to provide informed consent are not eligible and are unlikely to benefit from this screening approach.
Why it matters
Potential benefit: If successful, this approach could uncover previously unrecognized vertebral fractures on routine CTs and prompt earlier osteoporosis evaluation and treatment.
How similar studies have performed: Prior research using AI to detect vertebral fractures on CT scans has shown promising sensitivity and specificity, though results vary and routine clinical adoption is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.