NCT06449742

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: —

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.

Conditions

• Vertebral Fracture
• Osteoporosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-30
• Completion: 2027-03-01
• First posted: 2024-06-10
• Last updated: 2026-04-08

Locations

1 site across 1 country: Italy