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

Istituto Ortopedico Rizzoli100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Osteoporosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: At baseline (Day 0)

Secondary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, up to 2 years