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NCT Number: NCT06449742

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

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.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

About this study

This study aimed to evaluate the prevalence of vertebral fractures in a cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.It is estimated that 250 patients will be enrolled (Patients will be enrolled in retrospective and prospective way between 01/03/2025 and 28/02/2026. The presence of one or more vertebral fractures will be evaluated through the radiological medical assessment with automatic 3D reconstruction of the thoracic and lumbar spine and by application of the AI software NanoxAIHealthVCF NANO-X IMAGING LTD on abdomen-chest CT studies.

Clinical, anthropometric, and anamnestic data will be collected from patients undergoing CT assessments. These data will be collected on the day of the radiological examination.

There will be only one evaluation at the time of the CT scan. Only in case of fracture detection, via radiological medical assessment and/or via AI software, the patient will be subsequently evaluated in the Endocrinology Unit as for standard of care.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hospitalized patients
  • Patients known to have osteo-metabolic diseases.
  • 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)
  • Patients unable to understand and sign the Informed Consent.

Treatment and study plan

AI software and automatic 3D reconstruction

Diagnostic Test

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.

Primary outcomes

  1. Number of fractures detected with CT scans trough AI software and 3D reconstruction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Felipe, CRN

CONTACT

[email protected]

0226435062

Luigi Di Filippo, MD

CONTACT

[email protected]

0226435062

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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