Clinical trial NCT06085274: Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Official title: Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Invasive breast cancer
Indocyanine green
Sentinel lymph node biopsy
Neoadjuvant chemotherapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.
timeFrame: From Technetium-99 (Tc-99m) injection to the completion of surgery
Secondary outcomes:
measure: Complications/safety
timeFrame: From time of Technetium-99 (Tc-99m) injection to 30 days after surgery
measure: Patient reported outcome measures - Visual Analog Scale
timeFrame: From baseline/enrolment to 12 months from surgery
measure: Patient reported outcome measures - FACT-B+4
timeFrame: From baseline/enrolment to 12 months from surgery
measure: Patient reported outcome measures - Breast-Q
timeFrame: From baseline/enrolment to 12 months from surgery
Other outcomes:
measure: Budget impact analysis
timeFrame: 1 year
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: