NCT02583568已完成1 期
Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients With Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Tumor-to-background ratio
研究概览
简要总结
A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.
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
- 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
- •Females aged ≥ 18 years.
- •Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
- •Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data.
- •WHO performance score 0-
- •Life expectancy greater than 12 weeks
- •Written informed consent has been obtained
- •In the Investigator's opinion, patient is able and willing to comply with all trial requirements.
- •For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
- •A negative serum pregnancy test prior to receiving the second generation tracer
- •Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- •Breast prosthesis in the target breast
- •History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
- •Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
- •Significant renal or hepatic impairment.
- •Inadequately controlled hypertension with or without current antihypertensive medications.
- •History of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
- •Patients receiving anticoagulant therapy with vitamin K antagonists.
- •Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
- •Evidence of QT prolongation on pre-treatment ECG (Males >440 ms, Females >450 ms).
- •Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.
研究组 & 干预措施
Part 1
Experimental
In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)
干预措施: Bevacizumab-800CW (Drug)
Part 2
Experimental
In part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group.
干预措施: Bevacizumab-800CW (Drug)
结局指标
主要结局
Tumor-to-background ratio
时间窗: day 3
次要结局
- Number of participants with treatment-related adverse events(up to two weeks)
研究者
G.M. van Dam
prof.dr.
University Medical Center Groningen
研究点 (1)
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