Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer

NARecruitingINTERVENTIONAL
Enrollment

1,760

Participants

Timeline

Start Date

April 18, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

August 31, 2026

Conditions
Breast CancerSentinel Lymph Node Biopsy (SLNB)Sentinel Lymph Node DetectionSentinel Lymph NodeLymphatic MetastasisFluorescence ImagingIndocyanine Green (ICG)RadioisotopesLymph Node Mapping
Interventions
DRUG

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.

DRUG

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.

PROCEDURE

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.

Trial Locations (7)

Unknown

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

All Listed Sponsors
lead

Isabelle Henskens

OTHER

collaborator

Canisius-Wilhelmina Hospital

OTHER

collaborator

Spaarne Gasthuis

OTHER

collaborator

Noordwest Ziekenhuisgroep

OTHER

collaborator

Alrijne Hospital

OTHER

collaborator

Dijklander Ziekenhuis

OTHER

collaborator

Ziekenhuisgroep Twente

OTHER

collaborator

Diakonessenhuis, Utrecht

OTHER

collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

NCT07146295 - Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer | Biotech Hunter | Biotech Hunter