Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study

Summary

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.

Eligibility

Inclusion 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.

Exclusion Criteria:

* 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

Conditions3

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