Brain monitoring for high risk of brain metastases in metastatic breast cancer

Yonsei University Health System, Severance Hospital0 个研究点目标入组 200 人开始时间: 待定最近更新: 2019年4月23日

适应症

试验速览

暂无简介。

•1. Age = 19 years old
•2 Histologically or cytologically confirmed recurrent / metastatic breast cancer patients
•3 Breast cancer subtype that meets one of the following criteria:
•A. HER2 positive patients regardless of hormone receptor status or
•B. triple-negative breast cancer patients
•4 Patients scheduled to undergo systemic chemotherapy
•5 Patients who adhere to the study protocol during the clinical study period. Patients with signed consent by themseleves or their legal guardians who understand that they have the right to withdraw their consent at any time without penalty.

•1. History of prior treatments about brain metastases or leptomengeal metastases
•2. Symptomatic brain metastases at screening period
•3. Has received more than second-line systemic treatments (including endocrine therapy)
•4. For subjects who have difficulty lying down or who have claustrophobia, they can undergo sedation during brain MRI
•5. Patients with history of hypersensitivity reaction to contrast or antibiotics (e.g. penicilin, ampicilin), history of kidney disease, or impaired kidney function
•6. Patietns who inserted metallic prothesis (pacemaker, denture, hearing aid, anurysm clip, metallic material of eyeball, artifical joint, insulin pump, chemoport, temporary tissue expander for breast reconstruction, etc) can be conducted after consultation with investigator before MRI.
•7. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
•8. Participants who are sure to be excluded from this study or who can not be regular follow-up because of the following reasons:
•For example, Social, familial, or geographical factors that would interfere with study participation or follow-up
•9. In addition, participants who the investigator deems inappropriate for this study

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