None listed
Conditions
Brief 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.
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 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 min
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.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Participants enrolled in the ILST (men and women, aged 55-80 years, current or former smokers quit <15 years prior, >=30 pack-year smoking history and/or estimated lung cancer risk >=1.51% based on the PLCOm2012 risk prediction model, ECOG performance status 0 or 1) who are also volunteers in the ILST osteoporosis sub-study -Participants who provide written consent.
Exclusion criteria
Exclusion criteria per ILST: • Clinical symptoms suspicious for lung cancer Exclusion criteria: • Concurrent major medical illness (Any medical condition that, in the investigator’s opinion, may jeopardize the subject’s safety during participation in the study or mean that the subject is unlikely to benefit from screening due to shortened life expectancy) • Previous lung cancer • Other non-curatively treated non-pulmonary cancer or <5 years cancer-free if previous cancer • Pneumonia/bronchitis requiring antibiotics within previous 12 weeks • CT chest within the last 2 years • Received chemotherapy/other cytotoxic drugs within the last 6 months • Pregnancy • Unwilling/unable to have chest CT
Outcome results
None listed