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Clinical Trials in Italy / NCT06449742
Recruiting Observational

A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures

NCT06449742 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2025-03-01
Last updated
2026-04-08

Condition(s) studied

Vertebral FractureOsteoporosis

Investigational drug(s) / intervention(s)

AI software and automatic 3D reconstruction

AI software and automatic 3D reconstruction: Radiological medical evaluation with automatic 3D reconstruction of the thoracic and lumbar spine and through application of the AI software NanoxAIHealthVCF, NANO-X IMAGING LTD on abdomen-chest CT studies.

Study summary

The study will be conducted as a monocentric observational prospective study design wants to evaluate the prevalence of vertebral fractures in the cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.

Eligibility

Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of fractures detected with CT scans trough AI software and 3D reconstruction — from 01/03/2025 to 28/02/2026
    The UO of Endocrinology, in collaboration with the UO of Radiology of the IRCCS San Raffaele Hospital, proposes to assess the prevalence of vertebral fractures prospectively in the population afferent to our hospital to perform abdomen-chest CT studies through the radiological medical evaluation with automatic 3D reconstruction of the thoracic and lumbar spine and the application of the AI software cNanoxAIHealthVCF, NANO-X IMAGING LTD.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Ospedale San Raffaele Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06449742 on ClinicalTrials.gov ↗ ← All trials in Italy