The purpose of this study is to compare the current standard whole-body x-ray with the advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of myeloma bone lesions.
Accurate detection of bone lesions in myeloma patients is essential for treatment planning and patient survival. Newly diagnosed multiple myeloma patients can be enrolled in this study. All participants will at time of diagnosis undergo three project scans (FDG-PET-CT, NaF-PET-CT, whole-body MRI) as well as whole-body x-ray as part of clinical routine practice. Experienced specialists in the field of radiology and nuclear medicine interpret the images. Each reader performs the evaluations blinded to other imaging results as well as to the patient's clinical information. The reader assesses whether myeloma indicative bone lesions are present in eight predefined skeletal body regions. Endpoint is purely diagnostic. Statistics: Cochran's Q-test: to compare the proportion of patients with bone disease detected by the four scanning methods. Two-sided ANOVA: to compare the average number of regions detected with bone disease by the four scanning methods. Tukey's comparison test: to compare the difference between each pair of means.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
scanning method
scanning method
scanning method
Department of Radiology/Department of Nuclear Medicine
Herlev, Denmark
Bone metastases detection rate - a patient-based analysis
To compare the proportion of patients with bone disease detected by the four scanning techniques
Time frame: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
Bone metastases detection rate - a region-based analysis
To compare the number of affected regions with bone disease detected by the four scanning techniques
Time frame: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
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