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

University Medical Center Groningen (UMCG)

Status

Enrolling

Conditions

Breast Cancer

Breast Cancer Invasive

Treatments

Procedure: Fluorescence guided detection of tumor positive margins.

Study type

Interventional

Funder types

Other

Identifiers

NCT05939310

10975

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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