Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454617
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Calibr-Ì Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Calibr-Ì
Brief Summary:
Osteoporosis is a systemic disease characterized by a reduction in bone mineral density BMD and qualitative alteration of the skeleton resulting in increased bone fragility and fracture risk The epidemiological impact of osteoporosis is extremely high Proper diagnosis and clinical management of osteoporosis are critical to reducing the incidence of fragility fractures and preventing their complications The diagnosis is generally confirmed by instrumental analysis of bone mineral density The standard method is X-ray bone densitometry DXA which allows diagnosis based on criteria defined by the World Health Organization WHO by virtue of the T-score DXA is a relatively quick and inexpensive examination with low exposure to ionizing radiation However this method has limitations in detecting fracture risk and in addition not all patients are properly referred for DXA services which among other things require specific criteria to be reimbursed by the National Health System Currently computed tomography CT scanning is the most widely used three-dimensional diagnostic modality in clinical practice and the number of investigations performed in high-income countries is continuously growing Quantitative assessment of bone mineral density by CT is possible by proper calibration of the machine for the purpose of converting the CT numbers or Hounsfield units measured by the scanner into BMD units
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None