18F-FMAU for Imaging in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Radiation dosimetry of fluorine F 18 d-FMAU
研究概览
简要总结
This clinical trial studies the safety and drug distribution of the radioactive drug, 2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (fluorine F 18 d-FMAU [18F-FMAU]), for imaging with positron emission tomography/computed tomography (PET/CT) in patients with advanced cancers. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. PET/CT using the drug fluorine F 18 d-FMAU, may help find cancer and find out how far the disease has spread.
详细描述
PRIMARY OBJECTIVES:
I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse events in humans from intravenous (i.v.) injection of 18F-FMAU for PET imaging, and characterize the incidence of circulating metabolites of 18F-FMAU in humans.
II. To simply find out whether there is any visual uptake change of 18F-FMAU in tumors post-therapy.
OUTLINE:
Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer treatment. Patients may undergo 2 additional scans at one week prior to second course of chemotherapy and after completion of cancer treatment depending on cancer type.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with a malignancy/tumor/cancer, including but not limited to: brain tumor, breast cancer, lung cancer, esophageal cancer, lymphoma, or sarcoma
- •Have one or more tumors visualized by conventional PET-CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET-CT should be within one week prior to 18F-FMAU
排除标准
- •Have undergone chemotherapy or radiation therapy within the previous one month
- •Women of childbearing potential, unless they have had a negative urine beta human chorionic gonadotropin (betaHCG) within the previous 24 hours of the procedure
- •Patients who have had surgery at the site of the suspected lesion within 1 month
结局指标
主要结局
Radiation dosimetry of fluorine F 18 d-FMAU
时间窗: Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
Adverse events after injection of fluorine F 18 d-FMAU to the patients
时间窗: Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
Fluorine F 18 d-FMAU uptake change in tumors post-therapy
时间窗: Baseline up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
次要结局
未报告次要终点