Assessment of HER2 Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using 89 Zr-Trastuzumab
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration
研究概览
简要总结
The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years of age or older
- •Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 biopsy proven breast cancer
- •Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer
- •Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
- •Able to give informed consent
- •Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative
- •Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination.
排除标准
- •Patients with other invasive malignancies, with the exception of non- melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
- •Unable to tolerate 60 min of PET imaging per imaging session
研究组 & 干预措施
Cohort 1
89Zr-Trastuzumab Human Dosimetry and Safety
干预措施: 89Zr-Trastuzumab Human Dosimetry and Safety (Drug)
Cohort 1
89Zr-Trastuzumab Human Dosimetry and Safety
干预措施: HER2 Positive Lesion Detection and Safety (Drug)
Cohort 2: Lesion Detection and Safety
HER2 Positive Lesion Detection and Safety
干预措施: 89Zr-Trastuzumab Human Dosimetry and Safety (Drug)
Cohort 2: Lesion Detection and Safety
HER2 Positive Lesion Detection and Safety
干预措施: HER2 Positive Lesion Detection and Safety (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration
时间窗: 30 Days following 89Zr-Trastuzumab Administration
Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related.
次要结局
未报告次要终点
研究者
Farrokh Dehdashti
Professor of Radiology
Washington University School of Medicine