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RECRUITINGOBSERVATIONAL

AI Model for Bone Mineral Density Prediction From X-Ray Images

Development and Evaluation of an Artificial Intelligence Model for Bone Mineral Density Prediction From X-Ray Images

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Osteoporosis, a pervasive skeletal disorder characterized by diminished bone strength predisposing individuals to an increased risk of fractures, presents a substantial public health challenge globally. It's estimated that osteoporosis and its consequent increase in fracture risk significantly contribute to morbidity, mortality, and economic costs. Despite the availability of effective treatments, the condition often remains undiagnosed and untreated until a fracture occurs, underscoring the critical need for early detection and intervention. Dual-energy X-ray absorptiometry (DEXA) is the gold standard for assessing bone mineral density (BMD) and fracture risk. However, its utility is hampered by limited availability, especially in rural and low-resource settings, such as Bangladesh, where osteoporosis prevalence is notably high. The scarcity of DEXA units exacerbates the challenge of osteoporosis screening and management, leaving a significant portion of the population at risk In this context, plain X-ray imaging, widely available even in resource-constrained settings, emerges as a promising alternative for osteoporosis screening. Recent advancements in deep learning and computer vision offer the potential to automate the analysis of X-ray images for BMD estimation. The primary objective is to curate a comprehensive dataset of X-ray images of hip and spine as well as BMD reports and relevant clinical information sourced from local health facilities in Bangladesh encompassing diverse demographic data. The objective of this thesis is to develop and evaluate an Artificial Intelligence (AI)-based model that predicts BMD from plain X-ray images of the lumbar spine and pelvis. The proposed AI model processes X-ray images to detect subtle changes in bone texture and density, potentially offering a rapid, non-invasive, and cost-effective tool for large-scale osteoporosis screening, particularly beneficial in regions like Bangladesh where DEXA is scarcely available. This research addresses the critical gap in osteoporosis screening and diagnosis, aiming to contribute significantly to public health by enabling earlier detection and management of osteoporosis, thereby reducing the incidence of fractures and associated healthcare costs.

Who May Be Eligible (Plain English)

▪ Who May Qualify: - Female and male patients aged 18 and above - Individuals willing to participate and who have provided willing to sign a consent form for the use of their X-ray images and clinical data for research purposes. - Subjects with both X-ray images of hip and spine and DEXA scan results. - Accessibility to supplementary medical records that may contribute to the model's predictive accuracy, such as historical data on fractures, pregnancies, relevant medical conditions and other osteoporosis-related factors. - Who Should NOT Join This Trial: - Subjects for whom X-ray images or clinical data are incomplete or of insufficient quality for analysis. - Individuals with medical conditions that could significantly alter bone density independently of osteoporosis, such as bone cancers or certain metabolic diseases. - Subjects who have undergone treatments or procedures that might significantly impact bone density measurement, such as long-term steroid use or recent orthopaedic surgeries. - Pregnant women, given the potential impact on screening results and the need for special considerations during pregnancy. - Patients with implant in hip or spine Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
▪ Inclusion criteria: * Female and male patients aged 18 and above * Individuals willing to participate and who have provided informed consent for the use of their X-ray images and clinical data for research purposes. * Subjects with both X-ray images of hip and spine and DEXA scan results. * Accessibility to supplementary medical records that may contribute to the model's predictive accuracy, such as historical data on fractures, pregnancies, relevant medical conditions and other osteoporosis-related factors. * Exclusion criteria: * Subjects for whom X-ray images or clinical data are incomplete or of insufficient quality for analysis. * Individuals with medical conditions that could significantly alter bone density independently of osteoporosis, such as bone cancers or certain metabolic diseases. * Subjects who have undergone treatments or procedures that might significantly impact bone density measurement, such as long-term steroid use or recent orthopaedic surgeries. * Pregnant women, given the potential impact on screening results and the need for special considerations during pregnancy. * Patients with implant in hip or spine

Treatments Being Tested

DIAGNOSTIC_TEST

Dual Energy X-Ray Absorptiometry Scan (DEXA Scan)

A DEXA scan, or Dual-Energy X-ray Absorptiometry, is a specialized imaging technique used to measure Bone Mineral Density (BMD). It is commonly employed to diagnose osteoporosis and assess the risk of fractures, especially in areas prone to bone density loss, such as the spine, hip, and forearm. The scan works by using two low-energy X-ray beams that pass through the bone, allowing it to differentiate between bone and soft tissue and calculate the bone's density. DEXA is considered the gold standard for osteoporosis diagnosis due to its high accuracy and precision. The DEXA scan is a non-invasive, out-patient and painless procedure. Patients lie on an examination table while the scanner passes over the targeted area, typically the hip and spine. The entire procedure is straightforward, taking around 10 to 30 minutes depending on the areas being scanned.

DIAGNOSTIC_TEST

X-Ray (Hip and Spine)

Hip and spine X-rays are specific types of radiographic imaging used primarily to evaluate bone health, joint integrity, and alignment in these crucial areas. In the context of osteoporosis assessment, hip and spine X-rays can reveal signs of bone thinning or fractures, serving as an initial screening tool before more detailed imaging like a DEXA scan. During a hip X-ray, the patient typically lies on an examination table with the hip positioned for a clear view of the pelvis and femur. In a spine X-ray, the patient's posture may vary, often lying on the table in either a supine or lateral position to capture views of the vertebrae in the lower back (lumbar spine). Patients may be asked to remain very still, or even hold their breath momentarily, to prevent motion blur, which can obscure important details. Both hip and spine X-rays are quick and painless, generally taking only a few minutes, with the X-ray exposure itself lasting less than a second.

Locations (1)

Ibn Sina Diagnostic Centre, Uttara
Dhaka, Bangladesh