Trials / Completed
CompletedNCT03147326
Diagnostic Imaging of Myeloma Bone Lesions
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Herlev Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | FDG-PET-CT | scanning method |
| DIAGNOSTIC_TEST | NaF-PET-CT | scanning method |
| DIAGNOSTIC_TEST | Whole-body MRI | scanning method |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2015-09-01
- Completion
- 2017-04-01
- First posted
- 2017-05-10
- Last updated
- 2017-05-10
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03147326. Inclusion in this directory is not an endorsement.