Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Recruiting
N/A
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- University Health Network, Toronto · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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. Capab…
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