Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma
MYELOCHOL
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedStudy Start
First participant enrolled
November 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedJuly 23, 2025
July 1, 2025
3.2 years
March 25, 2019
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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
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
Day 7
Secondary Outcomes (6)
Diagnostic performance for the detection of focal bone lesions
Day 0
Diagnostic performance for the detection of focal bone lesions
Day 7
Diagnostic performances for the detection of diffuse infiltrative disease of the spine
Day 7
Diagnostic performances for the detection of diffuse infiltrative disease of the spine
Day 0
Number of extra-medullary lesions
Day 7
- +1 more secondary outcomes
Study Arms (1)
Symptomatic Multiple Myeloma on first-line treatment
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Symptomatic Multiple Myeloma on first-line treatment as defined by 2014 International Myeloma Working Group criteria
- Measurable disease either by serum or urinary monoclonal protein level or by serum free light chains assay
- Age \> 18 years old at time of signed consent
- Beneficiary of social security insurance
- Signed informed consent
You may not qualify if:
- Previous Multiple Myeloma treatment
- Previous cancer with less than 5 year of complete remission (including plasmacytoma)
- Uncontrolled diabetes mellitus
- Medullary growth factor injection less than 48 hours before imaging procedures
- Ongoing corticosteroid therapy, or given less than 72 hours before PET-CT imaging
- Pregnant or nursing (lactating) women
- Childbearing potential woman without adequate barrier contraception method (HAS criteria)
- Freedom deprivated patient by judiciary or administrative decision
- Patient under legal protection or unable to express its own consent
- PET contraindication (known allergy to 18F-FCH or 18F-FDG or excipient)
- MRI contraindication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bordeaux University Hospital - Haut-Lévêque
Pessac, 33604, France
Related Publications (1)
Mesguich C, Hulin C, Latrabe V, Asselineau J, Bordenave L, Perez P, Hindie E, Marit G. Prospective Comparison of 18F-Choline Positron Emission Tomography/Computed Tomography (PET/CT) and 18F-Fluorodeoxyglucose (FDG) PET/CT in the Initial Workup of Multiple Myeloma: Study Protocol of a Prospective Imaging Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e17850. doi: 10.2196/17850.
PMID: 32909953DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2019
First Posted
March 27, 2019
Study Start
November 12, 2019
Primary Completion
January 27, 2023
Study Completion
January 31, 2023
Last Updated
July 23, 2025
Record last verified: 2025-07