NCT01359267已完成早期 1 期
A Pilot Feasibility Study of 99mTc EC DG SPECT/CT Imaging in the Treatment Response Evaluation in Patients With Locally Advanced Head and Neck Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Persistent Disease within 6 months of CRT
研究概览
简要总结
The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.
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
- •Treatment naive patients with histologically proven cancer of the head and neck
- •T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)
- •At least one measurable site of disease
- •At least 18 years of age
- •Karnofsky performance status > or = 70% or ECOG <2
- •Able to tolerate SPECT/CT imaging
- •Adequate bone marrow function
- •Adequate liver function
- •Adequate renal function
- •Written consent from patients
- •Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study
排除标准
- •Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging
- •Patient weight above the SPECT/CT table weight limit
- •Pregnant and/or lactating female
- •Unequivocal demonstration of metastatic disease
- •Patients unwilling to or unable to comply with protocol
研究组 & 干预措施
Imaging
Experimental
干预措施: 99mTc-EC-DG (Drug)
结局指标
主要结局
Persistent Disease within 6 months of CRT
时间窗: 6 months
次要结局
- Persistent Disease within 2 years of CRT(2 years)
研究者
研究点 (1)
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