Multiple Myeloma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTFDG-PET-CT
scanning method
DIAGNOSTIC_TESTNaF-PET-CT
scanning method
DIAGNOSTIC_TESTWhole-body MRI
scanning method
Sponsors
Herlev Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed multiple myeloma (biopsy proven)
Exclusion criteria
* Prior malignancy * Are not able to undergo a MRI scan due to MRI contraindications (e.g. pacemaker) * Has any condition that places the subject at an unacceptable risk if he/she undergoes a diagnostic CT scan with iv. contrast (e.g. history of severe allergic reaction to the contrast agent) * Severe claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone metastases detection rate - a patient-based analysis | 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 | To compare the proportion of patients with bone disease detected by the four scanning techniques |
| Bone metastases detection rate - a region-based analysis | 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 | To compare the number of affected regions with bone disease detected by the four scanning techniques |
Countries
Denmark
Outcome results
None listed