Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)

What this Trial Is About

Researchers are evaluating the use of indocyanine green (ICG) fluorescence imaging to identify sentinel lymph nodes (SLNs) during mastectomy in women with clinically node-negative, invasive T1-T3 breast cancer. This pilot study aims to determine the diagnostic value of ICG-guided SLN biopsy performed through the mastectomy incision, potentially avoiding a separate axillary incision. The study compares ICG fluorescence with the standard 99mTc-nanocolloid method currently used for SLN detection. Participants receive a standard preoperative injection of 99mTc the day before surgery. During surgery, after anesthesia, 5 mg of ICG is injected near the areola. Surgeons then use near-infrared imaging to detect fluorescent lymph nodes through the mastectomy incision. The most fluorescent nodes are removed first, followed by nodes identified by the gamma probe for 99mTc activity. The axilla is checked visually and by palpation to ensure thorough node removal. All excised lymph nodes undergo pathological examination. During the procedure, researchers measure the detection rate of SLNs by ICG fluorescence compared to 99mTc, count the number of nodes identified by each method, and assess concordance and pathology differences. They also record detection time and surgical complications, including infections and lymphedema, up to two months after surgery. Participants are monitored during standard follow-up visits without extra discomfort or additional visits. The study is conducted at two hospitals and includes women aged 18 years or older.

Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)