NCT01050283终止1 期
A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 主要终点
- Association of changes in FDG uptake with overall survival (OS)
研究概览
简要总结
This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
- •Patient is scheduled to receive standard chemotherapy containing gemcitabine
- •Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
- •Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution
排除标准
- •Patient has had open abdominal surgery within 6 weeks of the screening visit
- •Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
- •Patient has an active infection, inflammation, or unresolved bowel obstruction
- •Patient has poorly controlled diabetes
研究组 & 干预措施
1
Experimental
[18F]-FDG-PET/CT (Computed Tomography) Imaging
干预措施: Comparator: [18F]-FDG PET/CT and Volumetric CT (Procedure)
结局指标
主要结局
Association of changes in FDG uptake with overall survival (OS)
时间窗: Week 3 and at least 7 months after the last patient is treated
次要结局
- Association of metabolic response with OS(Baseline, Week 3, and at least 7 months after the last patient is treated)
- Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7(Week 3 and Week 6-7)
研究者
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