Vertebral Fracture Clinical Trial
Official title:
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Verified date | June 2024 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study will be conducted as a monocentric observational retrospective and prospective case- control study design.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Male subjects - Age = 50 years old - Able to sign an informed consent - Avelability of anamnestic data Exclusion Criteria: - Hospitalized patients - Patients known for osteo-metabolic pathologies - Patients suffering from states of primary and/or acquired immunodeficiencies, and/or serious impairment of general clinical conditions (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacerbated/compensated chronic pathologies; moderate-severe renal insufficiency); - Patients unable to understand and sign the Informed Consent. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate potential differences between prevalences of vertebral fractures reported with AI software and in reports of clinical radiology | Evaluate potential differences between prevalences of vertebral fractures reported with AI software and in reports of clinical radiology in standard chest-abdomen CT scans performed for other indications than osteo-metabolic disease. | 1 day (There will be only one evaluation at the time of the CT scan.) |
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