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

NCT06449742 | Recruiting

• 1 other identifier: SMORFIA
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Fracture; Osteoporosis

Outcome Measures

Primary Outcomes (1)

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

  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.

  from 01/03/2025 to 28/02/2026

Study Arms (1)

Patients undergoing to CT abdomen-chest

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.

Diagnostic Test: AI software and automatic 3D reconstruction

Interventions

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.

Patients undergoing to CT abdomen-chest

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients, with an age ≥ 50 years old, that perform CT scan, without osteo-metabolic conditions.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Spinal Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrea Giustina, MD

  IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Di Filippo, MD

CONTACT

0226435062; difilippo.luigi@hsr.it

Gabriela Felipe, CRN

CONTACT

0226435062; felipe.gabriela@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Physician Specialist in Endocrinology

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: March 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)