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Recruiting NCT06085274

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICG guided sentinel lymph node biopsy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Complications/safety [Time frame: From time of Technetium-99 (Tc-99m) injection to 30 days after surgery]
  • Patient reported outcome measures - Visual Analog Scale [Time frame: From baseline/enrolment to 12 months from surgery]
  • Patient reported outcome measures - FACT-B+4 [Time frame: From baseline/enrolment to 12 months from surgery]
  • Patient reported outcome measures - Breast-Q [Time frame: From baseline/enrolment to 12 months from surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University Health Network — Toronto

Identifiers

NCT: NCT06085274 · 20-6215.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗