Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients

Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera.

Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.

• Percentage of SLNs that has 99mTc uptake/ is fluorescent [Срок оценки: through study completion, an average of 1 year]
• Detection time [Срок оценки: through study completion, an average of 1 year]
• Total operative time [Срок оценки: through study completion, an average of 1 year]
• Number of complications and (serious) adverse events [Срок оценки: through study completion, an average of 1 year]
• loco regional recurrence after 1 year follow-up [Срок оценки: through study completion, an average of 1 year]
• The pathology of SLNs identified [Срок оценки: through study completion, an average of 1 year]