Clinical trial · Interventional
Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study
Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study
NCT05939310CI-TRIAL-00076309MARGIN-2unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Invasive | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence guided detection of tumor positive margins. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluorescence guided surgery
- description
- 10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins.
- interventionNames
- Procedure: Fluorescence guided detection of tumor positive margins.
Primary outcomes (1)
- measure
- Detection
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (3)
- measure
- Detection ex-vivo imaging
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.