Diagnostic Imaging of Myeloma Bone Lesions
- Conditions
- Multiple Myeloma
- Interventions
- Diagnostic Test: FDG-PET-CTDiagnostic Test: NaF-PET-CTDiagnostic Test: Whole-body MRI
- Registration Number
- NCT03147326
- Lead Sponsor
- Herlev Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Newly diagnosed multiple myeloma (biopsy proven)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FDG-NaF-MRI FDG-PET-CT All participants will undergo three project scans/the following interventions: FDG-PET-CT NaF-PET-CT Whole-body MRI All participants will undergo a whole-body x-ray as part of clinical routine practice. FDG-NaF-MRI NaF-PET-CT All participants will undergo three project scans/the following interventions: FDG-PET-CT NaF-PET-CT Whole-body MRI All participants will undergo a whole-body x-ray as part of clinical routine practice. FDG-NaF-MRI Whole-body MRI All participants will undergo three project scans/the following interventions: FDG-PET-CT NaF-PET-CT Whole-body MRI All participants will undergo a whole-body x-ray as part of clinical routine practice.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Radiology/Department of Nuclear Medicine
🇩🇰Herlev, Denmark