NCT00959582已完成1 期
A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Proportion of patients with metabolic non-response assessed by FDG-PET standardized uptake value (SUV) 3 weeks and 6 weeks after starting platinum-based therapy
研究概览
简要总结
This study will characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as an early response marker in recurrent, platinum-sensitive ovarian cancer treated with platinum-based therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has ovarian, primary peritoneal, or fallopian tube cancer
- •Patient has first or subsequent relapse
- •Patient has had at least on prior platinum-based treatment for ovarian cancer
- •Patient is scheduled to receive treatment with carboplatin or cisplatin monotherapy or combination where one of the drugs is a platinum
- •Patient is not pregnant
排除标准
- •Patient has had abdominal surgery within the last 6 weeks
- •Patient has life expectancy < 6 months
- •Patient has had radiotherapy to the abdomen or pelvis within the last 6 months
- •Patient has poorly controlled diabetes
结局指标
主要结局
Proportion of patients with metabolic non-response assessed by FDG-PET standardized uptake value (SUV) 3 weeks and 6 weeks after starting platinum-based therapy
时间窗: Baseline, Week 3, Week 6
Progression free proportion
时间窗: 40 Weeks
次要结局
未报告次要终点
研究者
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