NCT01858116已完成1 期
An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer
Biomedical Radiation Sciences1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues
研究概览
简要总结
The study will evaluate [68Ga]ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer.
详细描述
Open-labeled, exploratory, single center study.
- Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four subjects with HER2-negative status. [68Ga]ABY-025 PET with low dose (100 μg) of ABY-025 peptide is performed, followed by a repeated PET within three weeks using high dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third [68Ga]ABY-025 PET will be performed in the HER2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the ABY-025 peptide dose previously determined to be preferable.
- Group 2 Ten subjects with HER2-positive primary tumor status. [68Ga]ABY-025 PET is performed using the ABY-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second [68Ga]ABY-025 PET investigation at signs of progressive disease or else latest after 9 months.
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
- •Diagnosis of invasive breast cancer with 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 metastasis lesions on CT or MRI, with at least one lesion >= 10 mm in smallest diameter and suitable for biopsy
- •ECOG performance status of =< 2
- •Life expectancy of at least 12 weeks
- •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 or else normal clearance
- •A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all female patients of childbearing potential, who must use a medically acceptable form of contraception from study start until at least 30 days after study termination
- •Subject is able to participate in the diagnostic investigations to be performed in the study
- •Informed consent
排除标准
- •Manifest second, non-breast malignancy
- •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 "Common Terminology Criteria for Adverse Events v4.0 [CTCAE]"
- •Other ongoing severe disease that may influence the patient's ability to participate in the study
- •Pregnant or breast-feeding
研究组 & 干预措施
[68Ga]ABY-025
Experimental
干预措施: [68Ga]ABY-025 (Drug)
结局指标
主要结局
PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues
时间窗: Day 0
次要结局
- Blood radioactivity kinetics and dosimetry of [68Ga]ABY-025(Day 0)
- SUV in metastases where biopsy results with HER2 status by IHC/FISH are available(Day 0)
- Uptake of [68Ga]ABY-025 coinciding with metastatic lesions visible on [18F]FDG PET and focal uptake in regions without pathological findings on [18F]FDG PET(Day 0)
- SUV for each measured lesion and number of detectable lesions, obtained with a low (100 μg) or high (500 μg) injected amount of ABY-025 peptide in the same subject(Day 0 & 1-3 weeks)
- Incidence and severity of adverse events(Day 0 to 42)
- SUVs for all measured lesions obtained with a low (100 μg) or high (500 μg) injected where biopsy results with HER2 status by IHC and FISH are available(Day 0)
- Anti-Drug Antibody assay at 3 and 6 weeks(Day 0 to 42)
- SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy(Up to 1 year)
研究者
Dr. Henrik Lindman, Oncology
Chief Physician
Uppsala University Hospital
研究点 (1)
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