Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma (MYELOCHOL)

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Myeloma Multiple

Treatments: Drug: Positron Emission Tomography using 18F-FDG; Drug: Positron Emission Tomography using 18F-FCH

Study type: Interventional

Funder types: Other

Identifiers

NCT03891914

CHUBX 2017/32

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Symptomatic Multiple Myeloma on first-line treatment

Experimental group

Treatment:

Drug: Positron Emission Tomography using 18F-FCH

Drug: Positron Emission Tomography using 18F-FDG