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

This pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients. Women with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St. Antonius or Isala Hospital will be included. All patients receive standard 99mTc injection preoperatively, followed by 5 mg (2mL) ICG injection after anesthesia. The axilla will be explored for fluorescent lymph nodes via the mastectomy incision, avoiding a separate axillary incision. Primary outcome: ICG detection rate for SLN identification via the mastectomy incision. Secondary outcomes: Comparison with 99mTc detection, number of nodes identified, concordance between methods, pathology differences, detection time, and complications. ICG is safe, non-ionizing, and causes no extra discomfort or visits. Risks and burden are minimal.

NCT Number	NCT07362485
Lead Sponsor	Isabelle Henskens Collaborators: Isala
Conditions	Breast Cancer, Sentinel Lymph Node Biopsy (SLNB), Sentinel Lymph Node Detection, Sentinel Lymph Node, Lymphatic Metastasis, Fluorescence Imaging, Indocyanine Green (ICG), Radioisotopes +2 more
Enrollment	90 participants
Start Date	2022-08-22
Primary Completion	2026-04 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-01-23