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NCT06085274 | RECRUITING | Breast Cancer

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

University Health Network, Toronto

Brief Summary:

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.

Condition or disease

Breast Cancer

Intervention/treatment

ICG guided sentinel lymph node biopsy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-04-30
Estimated Study Completion Date : 2026-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)

Location Details

NCT06085274

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Canada, Ontario

University Health Network

Toronto, Ontario, Canada, M5G2M9