Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Recruiting now NCT06085274
Run by University Health Network, Toronto · for 18 to 80 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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
Where this trial is running
- University Health Network, Toronto, Ontario, Canada
Who to contact
Tulin Cil, MD MSc FRCSC · 416-946-4501 · tulin.cil@uhn.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06085274.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.