1,760
Participants
Start Date
April 18, 2025
Primary Completion Date
July 31, 2026
Study Completion Date
August 31, 2026
Technetium (99mTc)
A radiopharmaceutical tracer consisting of technetium-99m (99mTc)-labelled nanocolloid used for sentinel lymph node mapping. In this study, 99mTc-nanocolloid is administered via periareolar injection with an activity of 40 MBq for the one-day protocol or 100 MBq for the two-day protocol, according to local hospital practice. Injection is performed either on the day of surgery or the afternoon before surgery. Preoperative lymphoscintigraphy is carried out to visualize lymphatic drainage. During surgery, a gamma-detection probe is used to locate and remove the sentinel lymph node(s) identified by 99mTc uptake.
Indocyanine Green
Indocyanine Green (ICG) is a fluorescent dye used for intraoperative sentinel lymph node mapping. In this study, a total dose of 5 mg (2 mL) of ICG is administered via periareolar injection after induction of general anesthesia and prior to axillary incision. During surgery, near-infrared fluorescence imaging is used to visualize lymphatic drainage and identify the sentinel lymph node(s). The identified node(s) are surgically removed under fluorescence guidance. In the transition phase, fluorescence findings are cross-checked against 99mTc uptake to ensure accuracy and safety.
Sentinel lymph node biopsy
Sentinel lymph node biopsy (SLNB) is a surgical procedure used to identify and remove the first lymph node(s) that drain lymph from a tumor area. In this study, SLNB is performed through a small axillary incision after mapping the sentinel lymph node(s) using either radioisotope technetium-labeled (99mTc)-nanocolloid, indocyanine green (ICG) fluorescence imaging, or a combination of both. The identified lymph node(s) are excised and sent for pathological examination to determine the presence of cancer cells. The procedure is carried out under general anesthesia as part of breast cancer surgery.
RECRUITING
Noordwest Ziekenhuisgroep, Alkmaar
RECRUITING
Ziekenhuisgroep Twente, Hengelo
RECRUITING
Spaarne Gasthuis, Hoofddorp
RECRUITING
Dijklander Ziekenhuis, Hoorn
RECRUITING
Alrijne Hospital, Leiden
RECRUITING
Canisius Wilhelmina Ziekenhuis, Nijmegen
RECRUITING
Diakonessenhuis, Utrecht
Isabelle Henskens
OTHER
Canisius-Wilhelmina Hospital
OTHER
Spaarne Gasthuis
OTHER
Noordwest Ziekenhuisgroep
OTHER
Alrijne Hospital
OTHER
Dijklander Ziekenhuis
OTHER
Ziekenhuisgroep Twente
OTHER
Diakonessenhuis, Utrecht
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER