A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male subjects
Age ≥ 50 years
Clinical and medical history data available at abdomen-chest CT evaluation
Signature of informed consent to the study
Disqualifiers
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.
Trial population
Male patients, with an age ≥ 50 years old, that perform CT scan, without osteo-metabolic conditions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AI software and automatic 3D reconstruction
Diagnostic testRadiological 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Patients undergoing to CT abdomen-chest1 intervention
Trial outcomes
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.
Time frame
from 01/03/2025 to 28/02/2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov