NCT05939310Unknown不适用
Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Detection
研究概览
简要总结
The goal of this clinical trial is to intraoperatively visualize tumour tissue in breast cancer patients using fluorescence imaging with the tracer bevacizumab-IRDye800CW and thereby enhance real-time clinical decision making, preventing postoperative tumour-positive margins.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are females with histologically proven carcinoma of the breast
- •The carcinoma of the breast is a local disease with limited size (but tumor size ≥ 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised.
- •Age ≥ 18 years
- •Written informed consent has been obtained
- •Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be 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
- •Non palpable breast tumor or prior surgery of this breast
- •Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW
- •History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment
- •Inadequately controlled hypertension with or without current antihypertensive medication
- •Significant renal or hepatic impairment (grade II or higher deviations by CTCAE)
- •History of allergy or infusion reactions bevacizumab or other monoclonal antibodies
- •Pregnant or lactating women
- •Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- •Life expectancy < 12 weeks
- •Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue
研究组 & 干预措施
Fluorescence guided surgery
Experimental
10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins.
干预措施: Fluorescence guided detection of tumor positive margins. (Procedure)
结局指标
主要结局
Detection
时间窗: 1 year
To determine whether real-time tumor visualization using targeted fluorescent imaging during breast conserving therapy in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor margin.
次要结局
- Radical resection rate(1 year)
- Detection in-vivo imaging(1 year)
- Detection ex-vivo imaging(1 year)
研究者
研究点 (2)
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