ACTRN12624000918527尚未招募Unknown
Appraising the utility of whole tumour heterogeneity assessment by novel HER2 PET scanning compared to standard-of-care FDG-PET scanning in metastatic breast cancer
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •HER2 positive or HER2 low metastatic breast cancer patient as defined by immunohistochemistry (IHC) measuring cell membrane HER2 protein and/or by in situ hybridisation (ISH) measuring the number of HER2 genes in each cell nucleus. HER2 positivity is defined as either strong (3+) cell membrane staining by IHC or amplification of the HER2 gene by ISH. Participants must be T-Dxd treatment naïve in the metastatic setting. The number of HER2 positive and HER2 low participants included in the study will be capped at five each (e.g. 5 HER2 positive and 5 HER2 low).
排除标准
- •Life expectancy less than 6 months, unable to give informed consent, unable to comply with required scanning schedule. May include conditions that increase the risk to the participant, that interfere with the participants ability to give informed consent or interfere with a participant’s ability to comply.
研究者
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