EUCTR2018-003926-10-FR进行中（未招募）1 期
Prospective comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the initial work-up of Multiple Myeloma - MYELOCHO
CHU de Bordeaux0 个研究点目标入组 30 人开始时间: 2018年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •- Symptomatic Multiple Myeloma on first-line treatment as defined by
- •2014 International Myeloma Working Group criteria
- •- Measurable disease either by serum or urinary monoclonal protein
- •level or by serum free light chains assay
- •- Age > 18 years old at time of signed consent
- •- Beneficiary of social security insurance
- •- Signed informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Previous Multiple Myeloma treatment
- •- Previous cancer with less than 5 year of complete remission
- •(including plasmacytoma)
- •- Chemotherapy in the 6 months preceding the inclusion
- •- Ongoing corticosteroid therapy, or given less than 72 hours before
- •PET-CT imaging
- •- Uncontrolled diabetes mellitus
- •- Medullary growth factor injection less than 48 hours before imaging
- •- Pregnant or nursing (lactating) women
- •- Childbearing potential woman without adequate barrier contraception
- •method (HAS criteria)
- •- PET contraindication
- •- MRI contraindication
- •Exclusion criteria after signed consent:
- •- Positive plasmatic ßHCG test before FCH-PET
- •- Blood glucose > 2,8 g/l before FDG-PET
研究者
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