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Recruiting NCT04349358

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

No phase Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FDG and FCH PET/CT.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other 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

Primary outcome measures

  • number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment [Time frame: before maintenance treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 3 centers
  • CHU de Besançon — Besançon
  • Centre Georges François Leclerc — Dijon
  • CHU de Dijon — Dijon

Identifiers

NCT: NCT04349358 · 2019-003627-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗