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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients. [Срок оценки: From Technetium-99 (Tc-99m) injection to the completion of surgery]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University Health Network — Toronto

Идентификаторы

NCT: NCT06085274 · 20-6215.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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