Using Indocyanine Green for Lymph Node Biopsy in Breast Cancer After Chemotherapy
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06085274 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown promising results with ICG in lymph node identification, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.