Actively Recruiting
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Led by University Health Network, Toronto · Updated on 2025-12-19
100
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 experience with this novel technique.
CONDITIONS
Official Title
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Stage I-III invasive breast cancer confirmed by core biopsy
- Completed neoadjuvant chemotherapy and planned for sentinel lymph node biopsy with dual tracer
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- No allergy to Indocyanine green or iodine
- Able to provide informed consent
- Literate in English
You will not qualify if you...
- Significant medical conditions classified as ASA 4
- Breast cancer stage T4 or inflammatory breast cancer, or N2 disease at presentation
- Clinically node positive after neoadjuvant therapy
- Previous axillary surgery or radiotherapy to the same breast or underarm
- Currently pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G2M9
Actively Recruiting
Research Team
T
Tulin Cil, MD MSc FRCSC
CONTACT
K
Karineh Kazazian, MD PhD FRCSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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