KCT0005042已完成未知
PET imaging of brain tumor using a 18F-FMT for tumor pharmacokinetics study: Microdose PET clinical trial
Korea Cancer Center Hospital0 个研究点目标入组 19 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Patients with a brain tumor
- •1. Patients with a primary or metastatic brain tumor with more-than-1.0 cm-diameter detected by MRI, CT, or F-18 FDG PET/CT scan
- •2. More than 3 weeks after the last chemotherapy or radiotherapy
- •3. Age = 18 years
- •4. The patient is capable of giving informed consent, complying with the restrictions and requirements of the protocol
- •5. In case of women in childbearing age, medically reliable contraception will be agreed.
- •Control subjects
- •1. No history of a brain tumor or other malignancy
- •2. Age = 18 years
- •3. The patient is capable of giving informed consent, complying with the restrictions and requirements of the protocol.
- •4. In case of women in childbearing age, medically reliable contraception will be agreed.
排除标准
- •1. Those who were judged as difficult to conduct the clinical trial due to serious medical conditions by the investigator.
- •2. Those who were judged to have a mental illness that makes it difficult to obtain positron emission tomography (PET) by the investigator.
- •3. Pre-menopausal women who are pregnant, lactating, or planning a pregnancy during the clinical trial period.
- •4. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of 18F-FMT PET images (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials).
- •5. Those who participated in other clinical trials that may affect the acquisition of 18F-FMT PET images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of 18F-FMT (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials).
- •6. Those who satisfy the following conditions in blood test
- •- absolute neutrophil count (ANC) < 1,000/µL
- •- hemoglobin < 8g/dL
- •- Platelet count (PLT) < 50,000/µL
- •- Serum creatinine > 3.0 x upper limit of normal (ULN)
- •- AST, ALT > 5.0 x upper limit of normal (ULN)
- •7. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
- •8. Vulnerable subjects (researchers or students who participated in research, family members, researchers or students of researchers participating in research)
研究者
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