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

NCT06085274 | Recruiting DMC

• 1 other identifier: 20-6215.0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.

  Proportion of lymph nodes identified with ICG compared to the proportion of lymph nodes identified with dual tracer (blue dye/Tc-99m gamma probe)

  From Technetium-99 (Tc-99m) injection to the completion of surgery

Secondary Outcomes (4)

• Complications/safety

  From time of Technetium-99 (Tc-99m) injection to 30 days after surgery

• Patient reported outcome measures - Visual Analog Scale

  From baseline/enrolment to 12 months from surgery

• Patient reported outcome measures - FACT-B+4

  From baseline/enrolment to 12 months from surgery

• Patient reported outcome measures - Breast-Q

  From baseline/enrolment to 12 months from surgery

Other Outcomes (1)

• Budget impact analysis

  1 year

Study Arms (1)

ICG-SLNB

EXPERIMENTAL

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.

Procedure: ICG guided sentinel lymph node biopsy

Interventions

ICG guided sentinel lymph node biopsy PROCEDURE

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.

ICG-SLNB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 and ≤ 80
• 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)
• Eastern Cooperative Oncology Group (ECOG) \< 2
• No ICG/iodine allergy
• Capable of providing informed consent
• English literacy

You may not qualify if:

• Significant medical comorbidities (ASA 4)
• Breast cancer stage T4/inflammatory or N2 disease at presentation (SLNB is contra-indicated in this setting)
• Clinical node positive after neoadjuvant therapy (SLNB is contra-indicated in this setting)
• Previous axillary surgery or breast/axillary radiotherapy to ipsilateral breast
• Active pregnancy or breastfeeding

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2M9, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Tulin Cil, MD MSc FRCSC

CONTACT

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

Karineh Kazazian, MD PhD FRCSC

CONTACT

4163403444; karineh.kazazian2@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 16, 2023
• Study Start: September 3, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CA (1)