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

NCT06454617 | Recruiting

• 1 other identifier: Calibr-I
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Definition of performance of internal calibration methods

  At baseline (Day 0)

• Optimization of existing internal calibration methods

  Through study completion, up to 2 years

Study Arms (1)

Experimental

Patients that require a TC scan.

Other: Phantom

Interventions

Phantom OTHER

The patients will be simultaneously scanned with a QCT phantom

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will involve a population of patients undergoing CT scans including the lumbar spine at the Diagnostic and Interventional Radiology Unit of each participating center. In CT scans requiring the administration of contrast medium, only the non-contrast-enhanced images will be considered.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital: collaborator

Study Sites (2)

The Rizzoli Orthopaedic Institute

Bologna, Bo, 40136, Italy

RECRUITING

Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital

Auckland, New Zealand

NOT YET RECRUITING

Related Publications (4)

• 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 23;68(1):1-39. doi: 10.4081/reumatismo.2016.870.

  PMID: 27339372 RESULT

• 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/s11657-021-00969-8.

  PMID: 35079919 RESULT

• 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 Densitom. 2015 Jul-Sep;18(3):393-407. doi: 10.1016/j.jocd.2015.06.010.

  PMID: 26277853 RESULT

• 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.

  PMID: 32059948 RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

Phantoms, Imaging

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Alberto Bazzocchi, MD

CONTACT

051636; alberto.bazzocchi@ior.it

Rebecca Sassi, MSc

CONTACT

051636; rebecca.sassi@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 6, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

NZ (1); IT (1)