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

Study Overview
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Brief Summary
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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.

Official Title
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Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study

Conditions
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Breast Cancer, Breast Cancer Invasive

Intervention / Treatment
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* Procedure: Fluorescence guided detection of tumor positive margins.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescence guided surgery<br>10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins. | Procedure: Fluorescence guided detection of tumor positive margins.<br>* Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection ex-vivo imaging | To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples. | 1 year | 
| Detection in-vivo imaging | To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity. | 1 year | 
| Radical resection rate | To analyze whether patients that in standard-of-care would have tumor-positive margins and needed additional treatment postoperatively, had a radical resection after biopsy using fluorescence guided surgery. | 1 year |