SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- SPECT-based 99mTc-ADAPT6 background uptake value (kcounts)
研究概览
简要总结
The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
- To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
- To assess kinetics of 99mTc- ADAPT6 in blood;
- To evaluate dosimetry of 99mTc- ADAPT6;
- To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:
详细描述
Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.
Phase I. Distribution of 99mTc-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
- To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
- To assess kinetics of 99mTc- ADAPT6 in blood;
- To evaluate dosimetry of 99mTc- ADAPT6;
- To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of primary breast cancer with possible lymph node metastases
- •Availability of results from HER2 status previously determined on material from the primary tumor, either
- •HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
- •HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
- •Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion > 1.0 cm in greatest diameter outside of the liver and kidneys
- •Hematological, liver and renal function test results within the following limits:
- •White blood cell count: > 2.0 x 10^9/L
- •Haemoglobin: > 80 g/L
- •Platelets: > 50.0 x 10^9/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 (serum beta-human chorionic gonadotropin, beta-HCG) at screening 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
- •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
结局指标
主要结局
SPECT-based 99mTc-ADAPT6 background uptake value (kcounts)
时间窗: 6 hours
Focal uptake of 99mTc-ADAPT6 in the regions without pathological findings will be assessed with SPECT and measured in kcounts
Tumor-to-background ratio (SPECT)
时间窗: 6 hours
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (kcounts)
SPECT-based 99mTc-ADAPT6 uptake value in tumor lesions (kcounts)
时间窗: 6 hours
99mTc-ADAPT6 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in kcounts
Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%)
时间窗: 6 hours
Whole-body 99mTc-ADAPT6 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
次要结局
- Safety attributable to 99mTc-ADAPT6 injections (physical findings)(24 hours)
- Safety attributable to 99mTc-ADAPT6 injections (laboratory tests)(24 hours)
- Safety attributable to 99mTc-ADAPT6 injections (concomitant medication)(24 hours)
- Safety attributable to 99mTc-ADAPT6 injections (incidence and severity of adverse events)(24 hours)