Using fluorescence imaging to improve breast cancer surgery outcomes
Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study
This study is testing if using a special imaging technique during breast cancer surgery can help doctors see tumors better and improve outcomes for women with localized breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 2 sites (Groningen and 1 other locations) |
| Trial ID | NCT05939310 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance surgical outcomes for breast cancer patients by using fluorescence imaging with the tracer bevacizumab-IRDye800CW. The goal is to visualize tumor tissue during surgery, allowing for real-time decision-making to prevent postoperative tumor-positive margins. Eligible participants are females with localized breast cancer who are advised to undergo breast-conserving therapy. The study will assess the effectiveness of this imaging technique in improving surgical precision and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 and older with histologically proven localized breast cancer suitable for breast-conserving therapy.
Not a fit: Patients with non-palpable breast tumors or those who have had prior surgery on the affected breast may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of cancer recurrence by ensuring complete tumor removal during surgery.
How similar studies have performed: Other studies utilizing fluorescence imaging in surgical oncology have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Groningen and 1 other locations
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Martini Ziekenhuis — Groningen, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.