Informations générales (source: ClinicalTrials.gov)
Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma (MYELOCHOL)
Interventional
Phase 3
University Hospital, Bordeaux (Voir sur ClinicalTrials)
novembre 2019
novembre 2022
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Bordeaux University Hospital - Haut-Lévêque - 33604 - Pessac - France | Charles MESGUICH, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- Previous Multiple Myeloma treatment
- Previous cancer with less than 5 year of complete remission (including plasmacytoma)
- Chemotherapy in the 6 months preceding the inclusion
- 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