Using Indocyanine Green for Lymph Node Biopsy in Breast Cancer After Chemotherapy
Official title: Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial
Run by University Health Network, Toronto · NCT06085274 · Data updated 2026-11-12
This study is testing if a special dye called Indocyanine Green can help doctors find lymph nodes more accurately during breast cancer surgery after chemotherapy, compared to the usual methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2029 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT06085274 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with stage I-III invasive breast cancer who have received neoadjuvant chemotherapy and are eligible for sentinel lymph node biopsy.
✕Probably not a fit
Patients with significant medical comorbidities, inflammatory breast cancer, or those who have had prior axillary surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of Indocyanine Green (ICG) guided sentinel lymph node biopsy (SLNB) in breast cancer patients who have undergone neoadjuvant chemotherapy. The study compares the accuracy of ICG with the standard dual-tracer method, assessing intraoperative outcomes and patient-reported experiences. Participants will receive ICG injections during surgery to identify sentinel nodes, and their outcomes will be measured against established protocols. The trial aims to determine if ICG can provide a non-inferior alternative to traditional methods.
Why it matters
Potential benefit: If successful, this approach could improve the accuracy and safety of lymph node biopsies in breast cancer patients post-chemotherapy.
How similar studies have gone: Previous studies have shown promising results with ICG in lymph node identification, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion 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. 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
Where it's running
-
University Health Network
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Tulin Cil, MD MSc FRCSC
- Email: tulin.cil@uhn.ca
- Phone: 416-946-4501
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.