KCT0002790招募中未知
PET imaging of breast cancer using 64Cu-NOTA-Trastuzumab for pharmacokinetics study: Microdose PET clinical trial
Korea Cancer Center Hospital0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 80(Year)（—）
- 性别
- Female
入选标准
- •1. Breast cancer patients
- •1) Histopathologically diagnosed breast cancer with HER2 expression
- •- HER2 positive (3+) or fluorescence in situ Hybridization (FISH) test in immunohistochemistry HER2 positive or silver in situ Hybridization (SISH) test HER2 positive
- •- At least one measurable lesion
- •- Patients with metastatic cancer can participate in clinical trials
- •2) HER2 expression is not observed histologically, but when serum HER2 expression is observed
- •- HER2 negative (-) or weak positive HER2 (1+)
- •- At least one measurable lesion
- •- serum HER2 positive
- •3) A control group with histologically diagnosed breast cancer with HER2-negative tumor
- •- HER2 negative (-) or weak positive HER2 (1+)
- •- At least one measurable lesion
- •2. Able to provide informed consent and have signed an approved consent form that conforms to institutional guidelines to ensure compliance
- •3. Patients from 40 to 80 years
- •4. Eastern Cooperative Oncology Group (ECOG) _ Performance scale =2
- •5. Life expectancy of greater than or equal to 12 months.
- •6. Those who satisfy the following conditions in blood test, renal function and liver function test
- •- absolute neutrophil count (ANC) = 1,500 / µL
- •- Hemoglobin = 9 g / dL
- •- platelet count (PLT)> 50,000 / µL
- •- Blood urea nitrogen (BUN) and serum creatinine <1.5 x normal upper limit (ULN)
- •- AST and ALT <2.5 x normal upper limit (ULN)
- •- If there is a history of heart disease, or 70 years or older, the left ventricular ejection coefficient > 60%
- •7. If the patient has recently received a HER2 target treatment, more than 4 months past from the last administration date
- •8. If chemotherapy or radiotherapy was performed recently, more than 3 weeks past from the last treatment date
- •you have received chemotherapy or radiotherapy recently, you may need to have received at least 3 weeks
排除标准
- •1. A person who is judged to be difficult to perform a clinical trial due to a serious medical condition
- •2. A person who has been found to have a mental illness that is difficult to perform PET
- •3. Pre-menopausal women who are pregnant or breastfeeding during screening, or who plan to become pregnant during the test
- •4. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of 18F-FDG or 18F-NaF 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-FDG or 64Cu-NOTA-Trastuzumab PET images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of 64Cu-NOTA-Trastuzumab
- •6. Those who are likely to influence the acquisition of 18F-FDG PET imaging due to unadjusted diabetes
- •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
- •9. Patients with trastuzumab hypersensitivity
研究者
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