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

University Health Network, Toronto

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: ICG guided sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06085274

20-6215.0

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ICG-SLNB

Experimental group

Description:

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.

Treatment:

Procedure: ICG guided sentinel lymph node biopsy