NL-OMON55969尚未招募不适用
HER Image: 89Zr-DFO* trastuzumab PET in patients with breast cancer - a pilot study - HER Image
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with:
- •- HER2+ or HER2-low breast cancer with metastatic disease,
- •- and starting systemic therapy or having stable, RECIST measurable disease
- •(with or without treatment).
- •A recent (< 16 weeks of start of study) biopsy confirming HER2-status, as
- •long as no therapy changes took place within those 16 weeks.
- •Able to undergo PET imaging procedures.
- •At least one lesion of at least 1.5 cm amenable for PET imaging
- •Age >18 years of age, willing and able to comply with the protocol as judged
- •by the investigator.
- •Signed written informed consent.
- •Have a World Health Organisation (WHO) performance status of 0-2.
- •Life expectancy of > 3 months.
- •Have measurable disease based on RECIST 1.1.
- •Adequate organ and bone marrow function, as deemed acceptable by the treating
排除标准
- •Contraindications for systemic treatment (as will be assigned by treating
- •physician).
- •Pregnant or lactating women.
- •Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- •Inability to comply with study procedures.
- •Has substance abuse or any other medical conditions such as clinically
- •significant cardiac or psychological conditions, that may, in the opinion of
- •the investigator, interfere with the subject*s participation in the clinical
- •study or evaluation of the clinical study results.
研究者
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