18F-Fluorocholine (FCH) versus 18F-Fluorodesoxyglucose (FDG) PET/CT for the detection of lesions in patients with multiple myeloma
- Conditions
- 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: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003627-38-FR
- Lead Sponsor
- Centre Georges-François Leclerc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 38
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 < 75 years.
5. Effective contraception for women of childbearing age.
6. Patient information and signature of informed consent or legal representative.
7.Patient able to remain in dorsal decubitus for 30 minutes.
8. Patient affiliated to a social security regimen or beneficiary of the
same according to local requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method