Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Recruiting now · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06085274
- Run by
- University Health Network, Toronto
- People needed
- 100
- Starts
- 2025-09-03
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2025-12-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- University Health Network — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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