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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: ICG guided sentinel lymph node biopsy

• Registration Number: NCT06085274
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-01
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Study Start: 2024-06-01
• Primary Completion: 2025-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG-SLNB	ICG guided sentinel lymph node biopsy	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.

Primary Outcome Measures

Name	Time	Method
Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.	From Technetium-99 (Tc-99m) injection to the completion of surgery	Proportion of lymph nodes identified with ICG compared to the proportion of lymph nodes identified with dual tracer (blue dye/Tc-99m gamma probe)

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome measures - Visual Analog Scale	From baseline/enrolment to 12 months from surgery	Patients' self-report the intensity of their pain. Scale 0-10, where 10 indicated worst pain possible.
Patient reported outcome measures - Breast-Q	From baseline/enrolment to 12 months from surgery	Breast cancer patients' self-report their perceptions of domains of Quality of Life. Scale 0-100; 100 indicates better satisfaction.
Complications/safety	From time of Technetium-99 (Tc-99m) injection to 30 days after surgery	Surgical intra-operative and post-operative complications will be collected to determine safety outcomes. All intra-operative complications will be graded using the ClassIntra classification. All post-operative complications (up to 30 days post-surgical treatment) will be graded using the Clavien-Dindo classification. Treatment-related adverse events will be assessed by CTCAE v5.0.
Patient reported outcome measures - FACT-B+4	From baseline/enrolment to 12 months from surgery	Breast cancer patients' self-report on various dimensions of their Quality of Life: Measures physical well-being (score range 0-28; higher score = worse outcome), social/family well-being (score range 0-28; higher score = better outcome), emotional well-being (score range 0-24; higher score = worse outcome), functional well-being (score range 0-28; higher score = better outcome), breast cancer subscale (score range 0-28; higher score = worse outcome), lymphedema subscale (score range 0-20; higher score = worse outcome).

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada