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

Not yet recruiting

• Conditions: Vertebral Fracture; Osteoporosis

• Registration Number: NCT06449742
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Study Start: 2025-03-01
• Primary Completion: 2025-11-30
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.