SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins HE3-G3 (99mTc-HE3-G3)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- SPECT-based 99mTc-HE3-G3 uptake value in tumor lesions (counts)
研究概览
简要总结
The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
- To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time;
- To evaluate dosimetry of 99mTc-HE3-G3;
- To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection:
The secondary objective are:
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-HE3-G3 in patients with primary breast cancer. The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
- To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time;
- To evaluate dosimetry of 99mTc-HE3-G3;
- To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection:
The secondary objective are:
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
- •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 immunohistochemical test score of 3+ or FISH positive or
- •HER2-negative, defined as a immunohistochemical test 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
- •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
研究组 & 干预措施
The tested injected doses of 99mTc-HE3-G3 1000 μg
At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 1000 μg.
Subjects withdrawn from the study for any reason will be replaced.
干预措施: SPECT (Drug)
The tested injected doses of 99mTc-HE3-G3 2000 μg
At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 2000 μg.
Subjects withdrawn from the study for any reason will be replaced.
干预措施: SPECT (Drug)
The tested injected doses of 99mTc-HE3-G3 3000 μg
At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg.
Subjects withdrawn from the study for any reason will be replaced.
干预措施: SPECT (Drug)
结局指标
主要结局
SPECT-based 99mTc-HE3-G3 uptake value in tumor lesions (counts)
时间窗: 6 hours
99mTc-HE3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based 99mTc-HE3-G3background uptake value (counts)
时间窗: 6 hours
Focal uptake of 99mTc-HE3-G3 in the regions without pathological findings will be assessed with SPECT and measured in counts
Gamma camera-based whole-body 99mTc-HE3-G3 uptake value (%)
时间窗: 6 hours
Whole-body 99mTc-HE3-G3 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
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-HE3-G3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-HE3-G3 uptake coinciding with the regions without pathological findings (counts)
次要结局
- Safety attributable to 99mTc-HE3-G3 injections (laboratory tests)(24 hours)
- Safety attributable to 99mTc-HE3-G3 injections (physical findings)(24 hours)
- Safety attributable to 99mTc-HE3-G3 injections (incidence and severity of adverse events)(24 hours)
- Safety attributable to 99mTc-HE3-G3 injections (concomitant medication)(24 hours)