FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Georges Francois Leclerc
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
FDG and FCH PET/CT
Other intervention* 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
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: FDG and FCH PET/CTOther 1 intervention
Trial outcomes
Primary outcomes
1
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment
PET/CT
Time frame
before maintenance treatmentSponsors and contacts
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Source ClinicalTrials.gov