A Phase II/III Study of Cyclotron-produced Tc-99m Pertechnetate (C-PERT) Efficacy and Safety in Patients With Conformed and Suspected Thyroid Cancer or Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- To demonstrate the efficacy of C-PERT (manufactured by the Edmonton PET Centre/ERC) in comparison to G-PERT (fromm approved commercial sources) using qualitative and quantitative clinical imaging biodistribtion data.
研究概览
简要总结
Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with ten patients using this imaging agent showed that it was safe and produced images with the same pattern as generator produced Pertechnetate. This study is now being done in larger numbers of patients to again show that the imaging pattern of both agents is the same, and to again demonstrate its safety.
详细描述
To demonstrate the efficacy of cyclotron-produced Tc-99m pertechnetate (C-PERT; manufactured by the Edmonton PET Centre/ERC) in comparison to generator-produced Tc-99m pertechnetate (G-PERT; from approved commercial source; using qualitative and quantitative clinical imaging biodistribution data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •thyroid cancer, or
- •Head and Neck cancer for salivary gland transfer
- •age 18-79
- •biochemical parameters < 5x ULN
- •WBC > 3.0/uL
- •ANC > 1.5/uL
- •platelets > 75,000/uL
- •hemoglobin > 10 g/dL
- •Karnofsky 50-100
排除标准
- •nursing or pregnant females
- •< 18 or > 79 Years
- •uncontrolled asthma
- •acute iritis
- •narrow angle glaucoma
- •previous radiation to head/neck
研究组 & 干预措施
C-PERT
45 patients with cancer
干预措施: C-PERT (Drug)
G-PERT
65 patients with cancer
干预措施: G-PERT (Drug)
结局指标
主要结局
To demonstrate the efficacy of C-PERT (manufactured by the Edmonton PET Centre/ERC) in comparison to G-PERT (fromm approved commercial sources) using qualitative and quantitative clinical imaging biodistribtion data.
时间窗: 5 months
次要结局
- To evaluate the safety of C-PERT from adverse event data(5 months)