A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Luigi Di Filippo, MD
- Phone Number: 0226435062
- Email: difilippo.luigi@hsr.it
Study Contact Backup
- Name: Gabriela Felipe, CRN
- Phone Number: 0226435062
- Email: felipe.gabriela@hsr.it
Study Locations
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Italy
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Milan, Italy, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele
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Contact:
- Luigi di Filippo, MD
- Phone Number: 5110 +39022643
- Email: difilippo.luigi@hsr.it
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Contact:
- Endocrinology Trial Office
- Phone Number: 8959 +39022643
- Email: trials.endocrinologia@hsr.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of fractures detected with CT scans trough AI software and 3D reconstruction
Time Frame: from 01/03/2025 to 28/02/2026
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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.
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from 01/03/2025 to 28/02/2026
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea Giustina, MD, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMORFIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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