Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans

Osteoporosis Clinical Trial

— Calibr-Ì  

Official title:

Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06454617
• Other study ID #: Calibr-I
• Status: Recruiting
• Start date: June 6, 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Alberto Bazzocchi, MD
• Phone: 051636
• Email: alberto.bazzocchi[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Both sexes.

• All ethnicities.

• Age equal or above 18 years.

• Any clinical indication (no specific pathology is required) for a CT scan of the lumbosacral spine or abdomen in which the entire lumbar spine (L1 to L5), paravertebral muscles, abdominal aorta, and subcutaneous adipose tissue are visible.

• Ability to give informed consent.

Exclusion Criteria:

• General contraindications to CT examination, including pregnancy or body weight/size exceeding scanner limits.

• Severe degenerative manifestations of the lumbosacral spine.

• Severe scoliosis of the lumbosacral spine.

• Surgical hardware that prevents adequate CT scanning.

• Oncologic pathology in progress or in recent history.

• Any other situation deemed incompatible with the study by the designated physician or investigator.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Phantom
The patients will be simultaneously scanned with a QCT phantom

Locations

Country	Name	City	State
Italy	The Rizzoli Orthopaedic Institute	Bologna	Bo
New Zealand	Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital

Countries where clinical trial is conducted

Italy,  New Zealand, 

References & Publications (4)

Engelke K, Lang T, Khosla S, Qin L, Zysset P, Leslie WD, Shepherd JA, Shousboe JT. Clinical Use of Quantitative Computed Tomography-Based Advanced Techniques in the Management of Osteoporosis in Adults: the 2015 ISCD Official Positions-Part III. J Clin De — View Citation

Michalski AS, Besler BA, Michalak GJ, Boyd SK. CT-based internal density calibration for opportunistic skeletal assessment using abdominal CT scans. Med Eng Phys. 2020 Apr;78:55-63. doi: 10.1016/j.medengphy.2020.01.009. Epub 2020 Feb 12. — View Citation

Rossini M, Adami S, Bertoldo F, Diacinti D, Gatti D, Giannini S, Giusti A, Malavolta N, Minisola S, Osella G, Pedrazzoni M, Sinigaglia L, Viapiana O, Isaia GC. Guidelines for the diagnosis, prevention and management of osteoporosis. Reumatismo. 2016 Jun 2 — View Citation

Willers C, Norton N, Harvey NC, Jacobson T, Johansson H, Lorentzon M, McCloskey EV, Borgstrom F, Kanis JA; SCOPE review panel of the IOF. Osteoporosis in Europe: a compendium of country-specific reports. Arch Osteoporos. 2022 Jan 26;17(1):23. doi: 10.1007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of different internal calibration methods	Compare the different methods of internal or phantomless calibration described in the literature with synchronous and asynchronous calibration in a population of patients undergoing CT scans that include the lumbar spine to assess their feasibility.	At baseline (Day 0)
Secondary	Definition of performance of internal calibration methods	Define the performance of various internal or phantomless calibration methods for the purpose of identifying the most appropriate and reliable technique.	At baseline (Day 0)
Secondary	Optimization of existing internal calibration methods	Optimize existing internal calibration methods, and eventually define a new phantomless targeted calibration protocol based on the results of the study.	Through study completion, up to 2 years