Patient with multiple myeloma, addressed for initial evaluation and eligible for an autograft of Hematopoietic Stem Cells. MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: 18F-Fluorocholine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N,N-dimethyl-N-fluoromethyl-2-hydroxyethylammonium
CAS Number: 44580-38-3
Other descriptive name: FLUO
Sponsors
Centre Georges-François Leclerc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient for whom an initial diagnosis of multiple myeloma has just been made, according to the IMWG definition presented in the introduction, and submitted for initial extension assessment before any specific myeloma treatment is started. 2. Patient with a therapeutic indication and eligible for autograft of Hematopoietic Stem Cells. 3. ECOG 0, 1 or 2 4. Age = 18 years et =65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: 1. Patient with a diagnosis with of MGUS (Monoclonal Gammapathy of Undetermined Significance ), indolent myeloma (“smoldering myeloma”), non-secreting myeloma or recurrence of myeloma. 2.Patient already on treatment for myeloma. 3. Patient not eligible for intensive treatment followed by autogreffe of Hematopoietic Stem Cells. 4. Patient with concomitant neoplasia. 5. Patient with a history of hematological or solid neoplasia, regardless of the time since diagnosis and histological type, except in the case of Basal Cell Carcinoma or adenocarcinoma in situ of the cervix. 6. Patient with a history of sarcoidosis. 7. Uncontrolled diabetes. 8. Long course corticosteroid patient, regardless of dose. 9. Patient undergoing treatment with hematopoietic growth factors (EPO, leukocyte or platelet growth factors) regardless of cause. 10. Patient in sepsis. 11. Claustrophobic patient. 12. Patient Refusal of Consent. 13. Pregnant or nursing woman. 14. Woman of childbearing age without effective contraception. 15. Person deprived of liberty or under guardianship (including curatorship). 16. Inability to undergo medical follow-up for geographic, social or mental reasons. 17. History of allergic reaction attributed to 18F-fluorodeoxyglucose or 18F-choline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the number of suspected hypermetabolic foci of myelomatous lesions detected in FCH PET and FDG PET during the initial assessment.;Secondary Objective: 1. Compare the number of suspected hypermetabolic foci of myelomatous lesions detected in FCH and FCH PET after the consolidation phase. 2. Determine the sensitivity and specificity of each examination, at the initial extension assessment and at the end of the consolidation phase, considering as true any hypermetabolic focus reported as suspect in FDG or FCH PET. 3. Characterize lesions with discordant fixation in FDG and FCH. 4.Assess the prognostic value on overall survival and without progression, during the initial assessment and at the end of the consolidation phase, of simple parameters in PET at FCH and FDG. 5. Evaluate the prognostic value for overall and progression-free survival, at the initial assessment and at the end of the consolidation phase, of more complex parameters in FCH and FDG. 6. Study the inter-observer concordance for the interpretation of FDG and FCH PET , at the initial diagnosis and at the end of the consolidation phase.;Primary end point(s): Number of hypermetabolic foci suspected of myelomatous lesions detected by PET at FCH compared to FDG PET at initial assessment. Number of lesions retained as myelomatous will be determined by a centralized review. Each PET scan will be evaluated blindly on the results of the PET scan performed with the other tracer, and blinded on the results of the other information in the patient file (clinical examination, biological results, other imaging results). Due to the intense physiological fixation of the liver in FCH PET, will be considered as myelomatous lesion, in FCH PET, any hyperfixative focus with a fixation intensity greater than that of the liver OR greater than that of the contralateral organ (for even organs) OR greater than the surrounding healthy tissue (for odd organs) and for which no further explanation can be giv | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Number of hypermetabolic foci suspected of myelomatous lesions detected by the 2 PET scans during the consolidation phase, using the same methodology as for the main judgement criterion. 2. In the absence of standard histological gold, any lesion retained as suspected of myelomatous localization by one of the 2 tests shall be considered as true. 3. Discordant lesions shall be described, specifying their locations, fixation intensities and morphological aspects. 4. Overall and progression-free survival of patients from the date of the first PET scan performed on the initial assessment. This judgement criterion will be used to meet the secondary objectives 4 and 5. 5. Inter-observer concordance will be assessed between the 3 central reviewers at the initial diagnosis and at the end of the consolidation phase.;Timepoint(s) of evaluation of this end point: Secondary End Points n°1, n°2, n°3 and n°6 : After 2 PET scans (FCH + FDG) performed after phase of consolidation therapy. Secondary End Points n°4 et n°5: 5 years after end of maintenance therapy. | — |
Countries
France
Contacts
Public ContactProject Manager/ Emilie Rederstorff
Centre Georges-François Leclerc
Outcome results
None listed