RecruitingNot ApplicableNCT06085274

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

Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial

Sponsor

University Health Network, Toronto

Enrollment

100 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This is a prospective, open-label, within-patient clinical trial to determine the accuracy of Indocyanine green (ICG) guided sentinel lymph node biopsy (SLNB) compared to the standard dual-tracer SLNB in breast cancer patients who have had chemotherapy as a first treatment using a non-inferiority design. Patients with operable breast cancer treated with chemotherapy and eligible for SLNB will be included in the study. During surgery, ICG will be injected and used to identify fluorescent sentinel nodes using a hand-held imaging camera; radiotracer and blue dye will also be used as per standard protocols. Intraoperative and clinicopathologic outcomes such as complications, characteristics of nodes, false negative rates and feasibility will be assessed. Patients will be asked to complete standardized patient reported outcome questionnaires (Breast-Q, FACT-B+4, VAS) to define the patient experience with this novel technique.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

Adults ≥ 18 and ≤ 80
Stage I-III core biopsy confirmed invasive breast cancer, who have undergone neoadjuvant chemotherapy and are planned to undergo SLNB with dual tracer (blue dye+Tc-99m)
Eastern Cooperative Oncology Group (ECOG) \< 2
No ICG/iodine allergy
Capable of providing informed consent
English literacy

Exclusion Criteria5

Significant medical comorbidities (ASA 4)
Breast cancer stage T4/inflammatory or N2 disease at presentation (SLNB is contra-indicated in this setting)
Clinical node positive after neoadjuvant therapy (SLNB is contra-indicated in this setting)
Previous axillary surgery or breast/axillary radiotherapy to ipsilateral breast
Active pregnancy or breastfeeding

Interventions

PROCEDUREICG 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.