Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
研究概览
简要总结
The purpose of this study is to determine if positron emission tomography (PET) imaging with an imaging agent called 18F-fluorodeoxythymidine([18F]-FLT) will allow investigators to measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy). Additionally, the investigators want to determine if it is possible to predict how well tumor(s) might respond to treatment with [18F]-FLT PET imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Subjects with known rectal cancer.
- •Subjects must have signed an approved consent form.
- •Subjects must be 18 years of age or older.
排除标准
- •Children less than 18 are excluded.
- •Pregnant women and women who are breast feeding will be excluded from this study. A serum beta HCG will also be performed for each pre-menopausal female subject.
- •Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
研究组 & 干预措施
[18F]-FLT PET scans
干预措施: PET imaging with [18F]-FLT (Device)
[18F]-FLT PET scans
干预措施: [18F]-fluorodeoxythymidine (Drug)
结局指标
主要结局
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
时间窗: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies
次要结局
- Correlative biology(at study entry before treatment, at week 3 of treatment, and at week 11 after treatment)
研究者
Henry C. Manning, PhD
Assistant Professor of Radiology, Neurosurgery, Biomedical Engineering, Program in Chemical and Physical Biology
Vanderbilt-Ingram Cancer Center