NL-OMON53445尚未招募2 期
Improving radical resection rates in patients with breast cancer by intraoperative imaging using bevacizumab-IRDye800CW - the MARGIN-2 study - Improving breast cancer radical resection rates using fluorescence imaging.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, the subject must meet all the
- •following criteria:
- •-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 -Received neo-adjuvant therapy with (near) complete
- •response -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.
研究者
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