NL-OMON39796已完成2 期
HER2-PET as a diagnostic tool in breast cancer patients with a clinical dilemma - Clinical value of 89Zr-trastuzumab
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. HER2-positivity is defined as:
- •a) HER2 immunohistochemical score of 3+, or
- •b) HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
- •2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
- •a) in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
- •b) in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
- •3. Standard work-up with imaging is defined as CT chest and abdomen, bone
- •scintigraphy, as well as FDG-PET.
- •4. Age >18 years of age.
- •5. WHO performance status 0-2.
排除标准
- •1. Pregnant or lactating women.
- •2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
研究者
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