SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Affibody Molecule-based Tracer 99mTc-ZHER2:41071.
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
- Gamma camera-based whole-body 99mTc-ZHER2:41071 uptake value (% per organ)
研究概览
简要总结
The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer
The primary objectives are:
- To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
- To evaluate dosimetry of 99mTc-ZHER2:41071;
- To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:
The secondary objectives are:
1. To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (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 targeted (trastuzumab or trastuzumab+pertuzumab) therapy.
Phase I. Distribution of 99mTc-ZHER2:41071 in patients with primary breast cancer.
The study should evaluate distribution of 99mTc-ZHER2:41071 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objectives are:
- To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
- To evaluate dosimetry of 99mTc-ZHER2:41071;
- To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:
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 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 > 2.0 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 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
- •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-ZHER2:41071 500 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.
Subjects withdrawn from the study for any reason will be replaced.
干预措施: SPECT (Drug)
The tested injected doses of 99mTc-ZHER2:41071 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.
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
Gamma camera-based whole-body 99mTc-ZHER2:41071 uptake value (% per organ)
时间窗: 24 hours
Whole-body 99mTc-ZHER2:41071 uptake coinciding with normal organs and tissues will be assessed using gamma camera at 2, 4, 6 and 24 hours after injection 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-ZHER2:41071 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ZHER2:41071 uptake coinciding with the regions without pathological findings (kcounts)
SPECT/CT-based 99mTc-ZHER2:41071 uptake value in tumor lesions (kcounts)/SUV
时间窗: 6 hours
99mTc-ZHER2:41071 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV
SPECT-based 99mTc-ZHER2:41071 background uptake value (kcounts)/SUV
时间窗: 6 hours
Uptake of 99mTc-ZHER2:41071 in the regions without pathological findings will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV.
次要结局
- Safety attributable to 99mTc-ZHER2:41071 injections (physical examination)(24 hours)
- Safety attributable to 99mTc-ZHER2:41071 injections (vital signs)(24 hours)
- Safety attributable to 99mTc-ZHER2:41071 injections (ECG )(24 hours)
- Safety attributable to 99mTc-ZHER2:41071 injections (blood laboratory tests)(24 hours)
- Safety attributable to 99mTc-ZHER2:41071 injections (urine laboratory tests)(24 hours)
- Safety attributable to 99mTc-ZHER2:41071 injections (incidence and severity of adverse events)(24 hours)
- Safety attributable 99mTc-ZHER2:41071 injections (concomitant medication)(24 hours)