Improving radical resection rates in patients with breast cancer by intraoperative imaging using bevacizumab-IRDye800CW – the MARGIN-2 study

niversity Medical Center Groningen0 个研究点目标入组 60 人开始时间: 2022年10月25日最近更新: 2023年7月18日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•-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
•-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.

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