CompletedPhase 3

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

France20 participantsStarted 2019-11-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of whole-body bone lesions

Timeframe: Day 0

Number of whole-body bone lesions

Timeframe: Day 7

Number of bone lesions within defined skeletal areas

Timeframe: Day 0

Number of bone lesions within defined skeletal areas

Timeframe: Day 7

Trial details

NCT IDNCT03891914

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-27

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