RecruitingACTRN12621001367831

Comparison of computed tomography scans (CT) and clinical risk tools to standard dual-energy X-ray absorptiometry scans (DXA) to detect osteoporosis and predict spinal fracture in lung cancer screening participants

Comparison of DXA to CT-based methods (CT Hounsfield unit attenuation value from the first lumbar vertebra [L1HU] and quantitative CT [QCT]) to detect osteoporosis and predict vertebral fracture in lung cancer screening participants

Sponsor

The University of Queensland

Enrollment

94 participants

Start Date

Sep 3, 2021

Study Type

Interventional

Conditions

Quantitative computed tomography Dual-energy x-ray absorptiometry Osteoporosis

Summary

The aim of this study is to compare the opportunistic use of chest computed tomography (CT) scans obtained as part of the International Lung Screening Trial (ILST) and clinical fracture risk prediction tools, against the reference standard dual-energy X-ray absorptiometry (DXA) scan to detect osteoporosis in lung cancer screenees. Who is it for? You may be eligible for this study if you are a lung cancer screening participant currently enrolled in the Queensland site (based at The Prince Charles Hospital) of the Osteoporosis Sub-study of the International Lung Screening Trial (ILST), and you are either due to have your second CT scan soon or have had your second CT scan within the past 6 months. Study details In addition to the CT scan received as part of the ILST trial and the osteoporosis questionnaires completed as part of the Osteoporosis sub-study of the ILST, all participants enrolled in this study will be requested to have a single DXA scan, This DXA scan will be performed either on the same day or different day to your CT scan, but should be within 6 months of the CT scan. The DXA study should only take up to 20 minutes and will be performed at The Prince Charles Hospital. It is hoped that this study will demonstrate that CT-based methods will be highly accurate, and have higher discriminative ability compared to clinical risk tools, in classifying DXA-defined osteoporosis, and therefore may validate their use in diagnosing osteoporosis in lung cancer screenees. This, in turn, may help to facilitate early diagnosis and treatment in this high-risk group of lung cancer screening participants.

Eligibility

Sex: Both males and femalesMin Age: 55 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Osteoporosis — a condition where bones become thin and fragile — is common in older adults, especially smokers. Many people don't know they have it until they break a bone. This study asks whether the CT scans already being done for lung cancer screening can also detect osteoporosis, potentially saving the need for a separate bone density scan (DXA). Participants in the International Lung Screening Trial (ILST) at The Prince Charles Hospital in Queensland are invited to also have a DXA scan. Researchers will compare what the CT scan shows about bone density with the results of the DXA scan, as well as with standard risk assessment questionnaires. The aim is to see whether the CT scan alone can reliably diagnose osteoporosis. You may be eligible if you are already enrolled in the ILST osteoporosis sub-study at the Queensland site and are due for your second CT scan or had it within the past six months. You need to be aged 55–80, a current or former smoker, and willing to have a DXA scan. People with a previous lung cancer diagnosis or other major illness are not eligible.

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Interventions

Participants who consent will have a single dual energy X-ray absorptiometry (DXA) scan within 6 months of their ILST low dose chest CT scan. DXA scans will measure the areal bone density from the

Participants who consent will have a single dual energy X-ray absorptiometry (DXA) scan within 6 months of their ILST low dose chest CT scan. DXA scans will measure the areal bone density from the femur and lumbar spine (L1-L4). T-scores will be calculated. Standard protocols for performing and reporting DXA scans will be followed. DXA scans will be performed by a trained Nuclear Medicine technologist and reported by a consultant Nuclear Medicine physician. The DXA scan will take up to 20 minutes to perform.