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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Other: Phantom

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Alberto Bazzocchi, MD; Phone Number: 6028 051636; Email: alberto.bazzocchi@ior.it
• Study Contact Backup: Name: Rebecca Sassi, MSc; Phone Number: 6028 051636; Email: rebecca.sassi@ior.it

Study Locations

• Italy
  • Bo
    • Bologna, Bo, Italy, 40136
      • Recruiting
      • The Rizzoli Orthopaedic Institute
      • Contact: Alberto Bazzocchi, MD, PhD; Phone Number: +39 051 636 6836; Email: abazzocchi@gmail.com
• New Zealand
  • Auckland, New Zealand
    • Not yet recruiting
    • Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital
    • Contact: Maria Pilar Aparisi Gómez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Patients that require a TC scan.	Other: Phantom; The patients will be simultaneously scanned with a QCT phantom

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: Calibr-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No