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

18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04349358
Acronym
MIM
Enrollment
38
Registered
2020-04-16
Start date
2020-12-15
Completion date
2030-12-15
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

PET/CT, FDG, Fluorocholine (18F) FCH

Brief 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.

Interventions

OTHERFDG 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

Sponsors

Centre Georges Francois Leclerc
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessmentbefore maintenance treatmentPET/CT

Countries

France

Contacts

Primary ContactEmilie REDERSTORFF
erederstorff@cgfl.fr03 43 34 81 16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026