Diagnostic Imaging of Myeloma Bone Lesions

Study Overview
=================
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.

Official Title
-----------------
The Diagnostic Value of FDG-PET-CT, NaF-PET-CT and Whole-body MRI Compared to Whole-body Xray in the Detection of Bone Lesions in Multiple Myeloma Patients

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Diagnostic Test: FDG-PET-CT
* Diagnostic Test: NaF-PET-CT
* Diagnostic Test: Whole-body MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FDG-NaF-MRI<br>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. | Diagnostic Test: FDG-PET-CT<br>* scanning method<br>Diagnostic Test: NaF-PET-CT<br>* scanning method<br>Diagnostic Test: Whole-body MRI<br>* scanning method<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone metastases detection rate - a patient-based analysis | To compare the proportion of patients with bone disease detected by the four scanning techniques | 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 | 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 |