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Clinical Trials in France / NCT04349358
Recruiting Not applicable

FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)

NCT04349358 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-12-15
Last updated
2023-10-17

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

FDG and FCH PET/CT

FDG and FCH PET/CT: * during the initial myeloma check-up : FDG and FCH PET/CT exams (maximum 21 days after inclusion) * just before maintenance treatment, respecting a minimum interval of 2 weeks after the last course of chemotherapy : FDG and FCH PET/CT exams

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 the trial for geographic, social or psychological reasons. * History of allergic reaction attributed to 18F-fluorodeoxyglucose or to 18F-fluorocholine.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
CHU de Besançon Besançon France Recruiting
Centre Georges François Leclerc Dijon France Recruiting
CHU de Dijon Dijon France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04349358 on ClinicalTrials.gov ↗ ← All trials in France