Overview
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Description
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.
Eligibility
Inclusion Criteria:
- Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy
- Preoperative axillary ultrasound to confirm clinical node-negative status
- Indication for breast cancer surgery with SLNB via axillar incision
- Written informed consent according to national regulations
Exclusion Criteria:
- Patients \< 18 years old.
- Indication for breast cancer surgery with SLNB via mastectomy incision
- Known allergy for ICG, intravenous contrast or iodine
- History of axillary lymph node dissection
- Pregnancy or breast-feeding
- Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol