EUCTR2012-003789-41-NL进行中（未招募）1 期
HER2-PET as a diagnostic tool in breast cancer patients with a clinical dilemma - Clinical value of 89Zr-trastuzumab PET
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. HER2-positivity is defined as:
- •i. HER2 immunohistochemical score of 3+, or
- •ii. HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
- •Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
- •i.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
- •ii.in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
- •Standard work-up with imaging is defined as CT chest and abdomen, bone
- •scintigraphy, as well as FDG-PET.
- •Age >18 years of age.
- •WHO performance status 0-2.
- •Signed written informed consent.
- •Able to comply with the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Pregnant or lactating women.
- •2.Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- •3.Inability to comply with study procedures
研究者
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