Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of whole-body bone lesions
研究概览
简要总结
Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the International Myeloma Working Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diagnosis, and could bring better baseline information than FDG PET for therapy evaluation. Ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18F-FDG in a recent retrospective study, with about 70% more lesions detected in MM patients with suspected relapsing disease. Following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our secondary objectives will be to compare the performance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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
- •Uncontrolled diabetes mellitus
- •Medullary growth factor injection less than 48 hours before imaging procedures
- •Ongoing corticosteroid therapy, or given less than 72 hours before PET-CT imaging
- •Pregnant or nursing (lactating) women
- •Childbearing potential woman without adequate barrier contraception method (HAS criteria)
- •Freedom deprivated patient by judiciary or administrative decision
- •Patient under legal protection or unable to express its own consent
- •PET contraindication (known allergy to 18F-FCH or 18F-FDG or excipient)
- •MRI contraindication
研究组 & 干预措施
Symptomatic Multiple Myeloma on first-line treatment
干预措施: Positron Emission Tomography using 18F-FCH (Drug)
Symptomatic Multiple Myeloma on first-line treatment
干预措施: Positron Emission Tomography using 18F-FDG (Drug)
结局指标
主要结局
Number of whole-body bone lesions
时间窗: Day 7
The numbers of bone lesions detected by 18F-FDG PET-CT, and that are suspected to be related to multiple myeloma, will be counted. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus.
Number of bone lesions within defined skeletal areas
时间窗: Day 7
Six skeletal areas are defined : skull - spine - pelvis - sternum and ribs - superior limbs - inferior limbs. The number of bone lesions that are suspected to be related to myeloma in each of these skeletal area is assessed on 18F-FDG PET-CT. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus
次要结局
- Diagnostic performance for the detection of focal bone lesions(Day 7)
- Diagnostic performances for the detection of diffuse infiltrative disease of the spine(Day 0)
- Number of extra-medullary lesions(Day 0)