FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM) (NCT04349358) | Clinical Trial Compass
RecruitingNot Applicable
FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)
France38 participantsStarted 2020-12-15
Plain-language summary
Hybrid positron emission tomography/computed tomography (PET/CT) has now become available to detect tumors in patients with multiple myeloma. The radioactive glucose 18F-fluorodeoxyglucose (FDG) is the most widely used tracer but findings suggest that PET/CT reveal more lesions when using FCH.
In this study, FDG is compared with a more recent metabolic tracer, 18F-fluorocholine (FCH), for the detection of multiple myeloma lesions at time of initial extension assessment.
The principal objective of this sudy is to compare the number of suspected hypermetabolic foci of myeloma detected by 18F-fluorocholine PET and by 18F-fluorodeoxyglucose PET during the initial extension assessment.
Who can participate
Age range
18 Years – 75 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:
* Patient with initial diagnosis of multiple myeloma has just been established
* Therapeutic indication and eligible for a HSC autograft (if the HSC autograft could not be performed, the patient will still be retained in the study).
* Status ECOG 0, 1 or 2
* Age ≥ 18 and \< 75 ans years
* Effective contraception for women
* Informed consent signed
* Patient able to lie flat for 30 minutes
* Patient affiliated to a social security scheme
Exclusion Criteria:
* Patient diagnosed with a diagnosis of MGUS (Monoclonal Gammapathy of Undetermined Significance = monoclonal gammopathy of undetermined significance), indolent myeloma ("smoldering myeloma"), non-secreting myeloma or recurrent myeloma,
* Patient already under treatment for myeloma.
* Patient not eligible for intensive treatment followed by a HSC autograft.
* Patient with concomitant neoplasia
* Patient with a history of hematological or solid neoplasia, except if it is a basal cell carcinoma of the skin or an adenocarcinoma in situ of the uterine cervix.
* Patient with a history of sarcoidosis
* Uncontrolled diabetes.
* Patient treated with long-term corticosteroids
* Patient being treated with hematopoietic growth factors
* Patient in sepsis.
* Claustrophobic patient.
* Refusal of patient consent.
* Pregnant or lactating woman.
* Women of childbearing potential without effective contraception.
* Person deprived of liberty or under guardianship
* Impossibility to submit to the medical follow-up of th…
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
1
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment