Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To describe imaging findings in human cancer with the new hypoxia tracer 124IAZGP and PET/CT
研究概览
简要总结
The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor. These low oxygen areas are thought to be the reason why tumors are more resistant to radiation treatment. A tracer is an extremely small quantity of a substance. Tracer to which radioactivity has been attached may be used to "trace" events in the body. A tracer called iodo-azomycin galactopyranoside (or *IAZGP) appears to be able to detect low oxygen areas within tumor.
Radioactive iodine in this molecule can be detected by an imaging technique called a PET scan. This present study involves obtaining three scans using this new imaging technique. The goal of carrying out many scans is to determine which scan will best show any areas in your tumor that may have low levels of oxygen.
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
- •Patients must have locally advanced cancer as determined by currently accepted diagnostic work-up, including CT/MR/US.
- •KPS >70%.
- •Patients must be > or equal to 18 years of age.
排除标准
- •Patients will be excluded from the study if they fulfill any of the following criteria:
- •Patients with abnormal baseline thyroid function tests, or any thyroid disorder including but not limited to hypothyroidism and thyroiditis. Patients with thyroid cancer who have had a thyroidectomy are not excluded.
- •Patients who are pregnant or lactating.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •Patients who cannot tolerate being in the PET scanner for the duration of the study.
结局指标
主要结局
To describe imaging findings in human cancer with the new hypoxia tracer 124IAZGP and PET/CT
时间窗: at least once at approximately 6 hours and/or 24 hours after radiotracer administration.
To evaluate the biodistribution of 124IAZGP using serial PET imaging and to estimate blood radioactivity
时间窗: 5, 15, 30 and 60 minutes after 124IAZGP, and before and after each. A 5-mL volume of blood will be drawn at each sampling time point.
To obtain further human dosimetry data with 124IAZGP
时间窗: 2 years
次要结局
未报告次要终点