A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
NCT ID: NCT06449742
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
250 participants
OBSERVATIONAL
2025-03-01
2027-03-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
MALE
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Luigi Di Filippo
Medical Physician Specialist in Endocrinology
Central Contacts
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Other Identifiers
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SMORFIA
Identifier Type: -
Identifier Source: org_study_id
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