Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Breast Cancer
Interventions
PROCEDURE

ICG guided sentinel lymph node biopsy

During sentinel lymph node biopsy the surgeon will inject a volume of 0.1ml divided into 2 doses (0.05ml each) of 2.5mg/mL ICG into the periareolar dermis of the involved breast. Technetium and blue dye will also be administered as per standard of care. The surgeon will assess the axilla with the the SPY-PHI near infrared imaging system to identify and remove ICG-fluorescent nodes; Any other sentinel lymph nodes identified will also be removed as per standard of care. If there is no progression of ICG towards the axilla, or if no ICG sentinel lymph node can be identified, an alternate injection technique involving peritumoural injection at 2-3 locations near the cancer site in the subcutaneous or dermal space of 0.05ml will be utilized.

Trial Locations (1)

M5G2M9

RECRUITING

University Health Network, Toronto

All Listed Sponsors
lead

University Health Network, Toronto

OTHER