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NCT06449742 Clinical Trial

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

Vertebral Fracture Clinical Trial

Official title:
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06449742
Other study ID # SMORFIA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2024

Study information
Verified date June 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study will be conducted as a monocentric observational retrospective and prospective case- control study design.

Description:

This monocentric, retrospective and prospective observational study wants to evaluate the diagnostic performances in identifying vertebral fractures of an artificial intelligence tool compared to radiologist in standard chest-abdomen CT scans performed for other indications than osteo-metabolic disease. 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 retrospectively and prospectively in the population afferent to our hospital, a level 3 diagnostic centre, to perform abdomen-chest CT studies in the year 2024 (period 01/01/2024-31/12/2024) through the application of the AI software NanoxAIHealthVCF, NANO-X IMAGING LTD. The specific population to be examined will be male patients over 50 years of age who perform an abdomen-chest CT examination at our center for clinical indications unrelated to osteometabolic diseases.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• IA Nanox AIHealthVCF
IA Nanox AIHealthVCF A(I software) will be used durint ct scan to identify vertebral fractures

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Outcome
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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