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.
Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy.
Preoperative axillary ultrasound to confirm clinical node-negative status.
Indication (or preference) for mastectomy and simultaneous SLN procedure.
Written informed consent according to ICH/GCP and national regulations.
Patients < 18 years old
Breast conserving surgery
Direct reconstruction (with autologous tissue or implant)
Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine
Single group
Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy
Other interventionICG-fluorescence is used as the primary tracer to identify SLNs during SLNB in breast cancer surgery. The standard 99mTc-nanocolloid method is used as a control to verify the sentinel lymph nodes identified by ICG. Surgeons are blinded to preoperative lymphoscintigraphy results. After general anesthesia, 5 mg (2 mL of 2.5 mg/mL solutio) of ICG is injected sub-/intracutaneous periareolarly. ICG-fluorescence is detected using near-infrared imaging. SLNB via mastectomy incision is performed. The most fluorescent lymph node is excised first, followed by (maximal 2) additional fluorescent nodes. The excised nodes are tested for 99mTc-activity using a gamma probe. The axilla is then checked with the gamma probe and and palpation for any remaining nodes, which are excised if their radiation count exceeds 10% of the hottest node. All excised lymph nodes are sent for pathological examination to determine the presence of cancer cells. After surgery, the lymphoscintigraphy results are announced.
Identification rate of sentinel lymph nodes using indocyanine green fluorescence
The identification rate is defined as the proportion of participants in whom at least one sentinel lymph node (SLN) is successfully identified using indocyanine green (ICG) fluorescence imaging via the mastectomy incision during surgery.
Identification rate of sentinel lymph nodes using 99mTc
The identification rate is defined as the proportion of participants in whom at least one sentinel lymph node is identified using the standard-of-care radioisotope technetium-99m (99mTc) during the same surgical procedure.
Difference in sentinel lymph node detection rate between ICG and 99mTc
The absolute difference in identification rates between indocyanine green (ICG) fluorescence imaging and technetium-99m (99mTc) for sentinel lymph node detection within the same participant.
Number of sentinel lymph nodes identified per participant by ICG and 99mTc
The total number of sentinel lymph nodes identified per participant using indocyanine green (ICG) fluorescence imaging and using technetium-99m (99mTc) during surgery.
Proportion of participants with fluorescent sentinel lymph nodes among those identified by 99mTc
The percentage of participants in whom sentinel lymph nodes identified by the standard-of-care technetium-99m (99mTc) are also fluorescent when assessed with indocyanine green (ICG).
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