NCT02095210终止1 期
Phase 1 Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
Dorte Nielsen2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2011年8月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression
研究概览
简要总结
This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A [18F]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product [68Ga]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age
- •Histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (LABC: T3-4NxMx or TxN2-3Mx)
- •HER2-positiv breast cancer first recurrence
- •HER2-positiv breast cancer primary metastatic
- •HER2 status has been determined on biopsy material from the primary tumour and found to be HER2-positive, defined as a DAKO HercepTest™ score of 3+ or else 2+ and FISH positive
- •[18F]FDG PET/ceCT performed within 7 days before administration of IMP
- •ECOG performance status of =< 2
- •Hematological, liver and renal function test results within the following limits:
- •White blood cell count: > 2.0 x 10^9/L
- •Haemoglobin: > 5.0 mmol/L
- •Platelets: > 50.0 x 10^9/L
- •ALT, ALP: =< 3 times Upper Limit of Normal
- •Bilirubin =< 2.0 times Upper Limit of Normal
- •Serum creatinine: Within Normal Limits
- •A negative pregnancy test (serum beta-HCG) at screening for all subjects of childbearing potential
- •Subject is capable to undergo the diagnostic investigations to be performed in the study
- •Informed consent
排除标准
- •Known hypersensitivity to Dotarem®
- •Active known autoimmune disease or history of autoimmune disease
- •Active serious infection according to investigator evaluation
- •Known HIV positive or chronically active hepatitis B or C
- •Administration of other investigational medicinal product within 30 days of screening
- •Pregnant or breast-feeding
- •Women capable of childbearing not using a sufficient non-hormonal method of birth control
- •Other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin
- •Signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the IMP, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.
结局指标
主要结局
to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression
时间窗: 28 days from last dose of study drug
次要结局
- 2. pharmacokinetics of [68Ga]ABY-025 and whole-body dosimetry of [68Ga]ABY-025(6 weeks after last dose of study drug)
- Assess concordance of [68Ga]ABY-025 uptake with [18F]FDG PET uptake before and after HER2 therapy(within 14 days before study drug)
研究者
Dorte Nielsen
Professor
Herlev Hospital
研究点 (2)
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