Status:
RECRUITING
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Lead Sponsor:
University Health Network, Toronto
Conditions:
Breast Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06085274
Start Date
September 3 2025
End Date
April 30 2026
Last Update
December 19 2025
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G2M9