A Phase 3 interventional study of Positron Emission Tomography using 18F-FCH and Positron Emission Tomography using 18F-FDG in Myeloma Multiple, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Diagnostic
Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the International Myeloma Working Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diagnosis, and could bring better baseline information than FDG PET for therapy evaluation. Ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18F-FDG in a recent retrospective study, with about 70% more lesions detected in MM patients with suspected relapsing disease. Following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our secondary objectives will be to compare the performance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 20 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Drug: Positron Emission Tomography using 18F-FCH · Drug: Positron Emission Tomography using 18F-FDG
Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FCH(or fluorocholine) for the detection of bone lesions
Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FDG (or fluorodeoxyglucose) for the detection of bone lesions
Number of whole-body bone lesions
The numbers of bone lesions detected by 18F-FCH PET-CT and that are suspected to be related to multiple myeloma, will be counted. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus.
Time frame: Day 0
Number of whole-body bone lesions
The numbers of bone lesions detected by 18F-FDG PET-CT, and that are suspected to be related to multiple myeloma, will be counted. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus.
Time frame: Day 7
Number of bone lesions within defined skeletal areas
Six skeletal areas are defined : skull - spine - pelvis - sternum and ribs - superior limbs - inferior limbs. The number of bone lesions that are suspected to be related to myeloma in each of these skeletal area is assessed on 18F-FCH PET-CT Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus
Time frame: Day 0
Number of bone lesions within defined skeletal areas
Six skeletal areas are defined : skull - spine - pelvis - sternum and ribs - superior limbs - inferior limbs. The number of bone lesions that are suspected to be related to myeloma in each of these skeletal area is assessed on 18F-FDG PET-CT. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus
Time frame: Day 7
Diagnostic performance for the detection of focal bone lesions
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FCH PET-CT will be calculated based on two different reference test. First reference test will be standard MRI sequences (T1SE, T2-STIR). Second reference test will be composed of standard MRI sequences plus whole-body diffusion MRI acquisitions.
Time frame: Day 0
Diagnostic performance for the detection of focal bone lesions
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FDG PET-CT will be calculated based on two different reference test. First reference test will be standard MRI sequences (T1SE, T2-STIR). Second reference test will be composed of standard MRI sequences plus whole-body diffusion MRI acquisitions.
Time frame: Day 7
Diagnostic performances for the detection of diffuse infiltrative disease of the spine
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FDG PET-CT will be calculated based on standard MRI sagittal acquisitions of the spine.
Time frame: Day 7
Diagnostic performances for the detection of diffuse infiltrative disease of the spine
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FCH PET-CT will be calculated based on standard MRI sagittal acquisitions of the spine.
Time frame: Day 0
Number of extra-medullary lesions
Each extra-medullary lesion detected on 18F-FDG PET-CT will be validated by an expert multidisciplinary consensus
Time frame: Day 7
Number of extra-medullary lesions
Each extra-medullary lesion detected on 18F-FCH PET-CT will be validated by an expert multidisciplinary consensus
Time frame: Day 0
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University Hospital, Bordeaux