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

Recruiting · NCT06085274 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

ICG guided sentinel lymph node biopsy

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.

Who can take part

Age range

18 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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

Exclusion criteria

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

Where it is running

1 location listed.

University Health Network - Toronto, Ontario, Canada

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →