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Trial Title:
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
NCT ID:
NCT06085274
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Invasive breast cancer
Indocyanine green
Sentinel lymph node biopsy
Neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ICG guided sentinel lymph node biopsy
Description:
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.
Arm group label:
ICG-SLNB
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Health Network
Address:
City:
Toronto
Zip:
M5G2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Tulin Cil, MD, MEd
Phone:
4169464507
Email:
tulin.cil@uhn.ca
Contact backup:
Last name:
Emma Reel, MSW
Phone:
6472021028
Email:
emma.reel@uhn.ca
Start date:
June 1, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085274
