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Идёт набор NCT06780735

Surgical Outcome of BCS Using ICG-F in Breast Cancer Patients After Preoperative Chemotherapy

Без фазы С лечением Breast Neoplasms Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The margin-positive rate using the localization technique.
Кому может быть актуально
Состояния в реестре: Breast Neoplasms, Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Surgical Outcome of Breast Conserving Surgery Using Indocyanine Green Fluorescence in Breast Cancer Patients After Preoperative Chemotherapy: a Prospective Study

Обзор

Neoadjuvant chemotherapy for advanced breast cancer has led to an increased rate of breast-conserving surgery (BCS) in these patients. As the demand for preoperative localization methods grows among surgeons performing BCS, traditional localization techniques have shown limitations. For non-palpable breast lesions, preoperative localization has commonly been achieved using ultrasound-guided skin markings or needle localization. However, these methods present challenges, including difficulty in depth localization for patients with large breasts and limitations in real-time re-verification during surgery due to air artifacts after incision. Needle localization, although commonly used, is invasive and poses risks such as displacement or detachment of the needle. Indocyanine green (ICG), a fluorescent dye that appears green to the naked eye and is detectable by near-infrared (NIR) cameras, has been widely and safely used in clinical practice via intravenous or subcutaneous administration. Recently, ICG combined with NIR imaging has been adopted for sentinel lymph node biopsy in breast cancer and melanoma surgeries and is increasingly used as a localization method for various tumors, replacing conventional techniques. A preliminary study (IRB No. NCC2016-0071) conducted at the institution evaluated ICG injection and NIR fluorescence imaging for tumor localization in early breast cancer patients undergoing BCS. The study demonstrated the efficacy of ICG-based localization in reducing the rate of positive surgical margins. The objective of this study is to evaluate the effectiveness of ICG-guided tumor localization with NIR fluorescence imaging in patients with advanced breast cancer treated with neoadjuvant chemotherapy. It is hypothesized that this technique will allow for more accurate tumor excision compared to conventional methods, ultimately improving surgical outcomes.

Вмешательства

  • Процедура The margin-positive rate using the localization technique
    Localization of breast cancer using indocyanine green fluorescence (ICG-F)

Первичные конечные точки

  • Margin-positive rate in final pathological report [Срок оценки: 10~35 days after surgery (the date when the pathological reports are available)]
Вторичные конечные точки (6)
  • Localization rate [Срок оценки: The day of surgery]
  • Centralization [Срок оценки: 10~35 days after surgery (the date when the pathological reports are available)]
  • Margin-positive rate in frozen section [Срок оценки: The day of surgery]
  • Additional resection rate [Срок оценки: The day of surgery]
  • Re-excision rate [Срок оценки: 10~35 days after surgery (the date when the pathological reports are available)]
  • Adverse event rate [Срок оценки: 10~35 days after surgery (the date of follow-up after surgery)]

Критерии участия

Критерии включения

  • The Patient with locally advanced breast cancer who is eligible for breast-conserving surgery after receiving neoadjuvant chemotherapy
  • Aged over 18 years old
  • ECOG performance status: 0 or 1
  • The patients with written informed consent

Критерии исключения

  • The patient who requires total mastectomy after receiving neoadjuvant chemotherapy
  • The patient with no residual mass on ultrasonography or only with microcalcifications
  • Pregnant or lactating patient
  • The patient with a disability to understand and provide consent
  • The patient with severe allergic history to indocyanine green
  • Iodine-sensitive patient

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • National Cancer Center — Goyang-si

Идентификаторы

NCT: NCT06780735 · NCC-2310621-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗