NCT02490891已完成2 期
Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Measure of angiogenesis with RGD K5 PET scan
研究概览
简要总结
The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass
详细描述
After inclusion PET scans with FDG tracer and with a specific tracer of angiogenesis will be performed on patient with lymphoma. After two cycles of chemotherapy PET scans with the same tracers will be performed.
Overall survival and disease free survival will be monitored during 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
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
- •Male or Female
- •Age ≥ 18 years old
- •Histological diagnosis of diffuse large B-cell lymphoma what ever the subtype
- •Presence of measurable tumor with at least a node mass superior to 3 centimeters
- •Stage I to IV
- •Inform consent signed
排除标准
- •Primary cerebral lymphoma
- •Absence of fixing on FDG-PET exam
- •Pregnant , child bearing, breast feeding or without effective contraception method woman
- •Hypersensitivity to RGD-K5
- •Hypersensitivity to FDG
- •Poorly controlled diabètes (glycemia ≥ 10 millimoles/liter)
- •Neoplastic disease (less than 2 years or in progression)
研究组 & 干预措施
PET scan with RGD K5 imaging
Experimental
PET scan with RGD K5 tracer will be performed before and after two cycles of chemotherapy
干预措施: RGD K5 PET scan (Device)
结局指标
主要结局
Measure of angiogenesis with RGD K5 PET scan
时间窗: 3 months
Measure of fixation, metabolic volume and angiogenic volume with RGD K5 traver
次要结局
- Measure of angiogenic volume with K5 tracer(3 months)
- Overall survival(18 months)
- Disease-free survival(18 months)
研究者
研究点 (2)
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