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

RecruitingNAAges 18 Years - 80 YearsAllUniversity Health Network, Toronto
NCT06085274 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ex

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults ≥ 18 and ≤ 80 2. 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) 3. Eastern Cooperative Oncology Group (ECOG) \< 2 4. No ICG/iodine allergy 5. Capable of providing informed consent 6. English literacy Exclusion Criteria: 1. Significant medical comorbidities (ASA 4) 2. Breast cancer stage T4/inflammatory or N2 disease at presentation (SLNB is contra-indicated in this setting) 3. Clinical node positive after neoadjuvant therapy (SLNB is contra-indicated in this setting) 4. Previous axillary surgery or breast/axillary radiotherapy to ipsilateral breast 5. Active pregnancy or breastfeeding
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What it tests

  • ICG guided sentinel lymph node biopsy
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Where

1 site
University Health Network
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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