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临床试验/EUCTR2019-003627-38-FR
EUCTR2019-003627-38-FR进行中(未招募)1 期

18F-Fluorocholine (FCH) versus 18F-Fluorodesoxyglucose (FDG) PET/CT for the detection of lesions in patients with multiple myeloma - MIM

Centre Georges-François Leclerc0 个研究点目标入组 38 人开始时间: 2019年10月21日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
38

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • 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

排除标准

  • 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.

研究者

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