Recruiting

Sentinel Lymph Node Biopsy

Sponsor:

University Health Network, Toronto

Code:

NCT06085274

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ICG guided sentinel lymph node biopsy

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06085274

Start date

Sep 3, 2025

Status verified date

Dec, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ICG-SLNB

This is a prospective within-patient clinical study to assess the accuracy of ICG SLNB compared to standard dual-tracer SLNB in breast cancer patients treated with neoadjuvant chemotherapy. For SLNB, triple localization of the sentinel lymph nodes using blue dye, Tc-99m and ICG will be utilized in each patient.

Interventions

ICG guided sentinel lymph node biopsy

During sentinel lymph node biopsy the surgeon will inject a volume of 0.1ml divided into 2 doses (0.05ml each) of 2.5mg/mL ICG into the periareolar dermis of the involved breast. Technetium and blue dye will also be administered as per standard of care. The surgeon will assess the axilla with the the SPY-PHI near infrared imaging system to identify and remove ICG-fluorescent nodes; Any other sentinel lymph nodes identified will also be removed as per standard of care. If there is no progression of ICG towards the axilla, or if no ICG sentinel lymph node can be identified, an alternate injection technique involving peritumoural injection at 2-3 locations near the cancer site in the subcutaneous or dermal space of 0.05ml will be utilized.

Primary outcome measure

  • Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients. [ Time Frame: From Technetium-99 (Tc-99m) injection to the completion of surgery ]

Central Contacts and Locations

Central contacts

Tulin Cil, MD MSc FRCSC

416-946-4501tulin.cil@uhn.ca

Karineh Kazazian, MD PhD FRCSC

4163403444karineh.kazazian2@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2M9

Contacts

Tulin Cil, MD, MEd

4169464507tulin.cil@uhn.ca

Emma Reel, MSW

6472021028emma.reel@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • Invasive breast cancer
  • Indocyanine green
  • Sentinel lymph node biopsy
  • Neoadjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-19.