RecruitingNot ApplicableNCT07362485

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

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

Sponsor

Isabelle Henskens

Enrollment

90 participants

Start Date

Aug 22, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Mastectomy Sentinel Lymph Node Biopsy (SLNB)Sentinel Lymph Node Detection Sentinel Lymph Node Lymphatic Metastasis Fluorescence Imaging Indocyanine Green (ICG)Radioisotopes Lymph Node Mapping

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria8

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
Other concurrent solid tumour
Hyperthyroidism or thyroid cancer
Pregnancy or breast feeding
Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol

Interventions

OTHERIndocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy

ICG-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.