SPECT/CT Imaging of Different Types of HER2 Expression in Breast Cancer Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- [99mTc]Tc -ZHER2:4107 background uptake
研究概览
简要总结
The study should evaluate the [99mTc]Tc -ZHER2:4107 accumulation in primary tumour of breast cancer patients with different HER2 expression
详细描述
To determine different HER2 expression in primary breast cancer patients before any system or local treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age
- •Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
- •Hematological, liver and renal function test results within the following limits:
- •White blood cell count: > 2.0 x 109/L
- •Hemoglobin: > 80 g/L
- •Platelets: > 50.0 x 109/L
- •ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
- •Bilirubin =< 2.0 times Upper Limit of Normal
- •Serum creatinine: Within Normal Limits
- •A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
- •Subject is capable to undergo the diagnostic investigations to be performed in the study
- •Informed consent
排除标准
- •Any system therapy (chemo-/targeted therapy)
- •Second, non-breast malignancy
- •Active current autoimmune disease or history of autoimmune disease
- •Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening), known HIV positive or chronically active hepatitis B or C
- •Administration of other investigational medicinal product within 30 days of screening
- •Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
研究组 & 干预措施
HER2-positive status (IHC 3+)
Patients with HER2-positive status (IHC 3+)
干预措施: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT (Drug)
IHC 1+ HER2 expression
Patients with IHC 1+ HER2 expression
干预措施: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT (Drug)
IHC 0 HER2 expression
Patients with IHC 0 HER2 expression
干预措施: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT (Drug)
结局指标
主要结局
[99mTc]Tc -ZHER2:4107 background uptake
时间窗: 2 hours
SPECT-based \[99mTc\]Tc -ZHER2:41 background uptake value (SUVmax)
Tumor-to-background ratio
时间窗: 2 hours
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc -ZHER2:41 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc -ZHER2:41 uptake coinciding with the regions without pathological findings (SUVmax)
[99mTc]Tc -ZHER2:4107 uptake in primary breast tumor
时间窗: 2 hours
SPECT/СT-based \[99mTc\]Tc -ZHER2:4107 uptake in primary breast tumor with different HER2 expression (SUVmax)
次要结局
- Differentiation of HER2 expression in primary tumors(2 hours)