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

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Osteoporosis; Vertebral Fracture

Treatments: Diagnostic Test: AI software and automatic 3D reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT06449742

SMORFIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 1 patient group

Patients undergoing to CT abdomen-chest

Description:

Patients undergoing to CT abdomen-chest study at the UO of Radiology of the IRCCS San Raffaele Hospital for clinical indications not related to osteo-metabolic pathology. Patients will be evaluated for vertebral fractures both through the 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.

Treatment:

Diagnostic Test: AI software and automatic 3D reconstruction