PET imaging of breast cancer using 64Cu-DOTA-Trastuzumab for evaluating HER2 expression: Investigator Initiated Trials

Korea Cancer Center Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新: 2019年3月11日

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

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. 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
•- 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 64Cu-DOTA-Trastuzumab 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-DOTA-Trastuzumab images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of64Cu-DOTA-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

发起方

Korea Cancer Center Hospital

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